Evolut now has CE mark for low-risk patients and has new labelling for bicuspid use

Evolut Medtronic has been awarded CE mark for the use of the Evolut transcatheter aortic valve implantation (TAVI) system for patients with severe native aortic stenosis who are at low surgical risk. The Evolut TAVI platform has also received a new indication approval for the treatment of patients with bicuspid aortic valves [...]

2020-06-23T11:39:41+00:00June 23rd, 2020|Tags: , , |

Foldax closes US$20 million financing

Foldax has announced the closing of a $20 million Series D round of funding. According to a press release, MemorialCare Innovation Fund (MCIF) led the round, with Angel Physicians Fund (APF) and Sayan Bioventures joining as new investors. All existing investors also participated in the round, including BioStar Capital, Kairos Ventures and Caltech. Brant [...]

2020-06-23T11:23:10+00:00June 23rd, 2020|Tags: , , , , |

Rexgenero acquires assets of aratinga.bio SAS Group

A press release reports that Rexgenero has acquired all the key technology and program assets of aratinga.bio SAS Group. It adds that the acquisition, which follows the recent approval by the French Commercial Court, includes all patent applications and related intellectual property, the exclusive license agreement for polymeric nanoparticle technology and the bioproduction facilities [...]

2020-06-23T11:17:08+00:00June 23rd, 2020|Tags: , , |

Abiomed initiates online education platform for PCI

Members of CAMP PCI’s faculty take questions from physician participants during the first virtual training on 5 June 2020, broadcast live from Abiomed’s Heart Recovery Institute Abiomed has launched a virtual physician education programme, CAMP PCI (Coronary artery and myocardial protected percutaneous coronary intervention), to improve high-risk PCI patient outcomes. A press [...]

2020-06-19T11:37:19+00:00June 19th, 2020|Tags: , , |

Vaseem Mahboob steps down as CFO of Endologix

Endologix has announced that Vaseem Mahboob, chief financial officer (CFO), will be departing the company effective 1 July 2020 to become CFO of a private global healthcare company. Cindy Pinto, vice president, Financial Planning & Analysis, will assume the role of interim CFO in addition to her current responsibilities, and Endologix has initiated a [...]

2020-06-19T11:32:45+00:00June 19th, 2020|Tags: , |

Smartphone could be used to detect fluid in the lungs

A study, by Offer Amir (Heart Institute, Hadassah Medical Centre, Jerusalem, Israel) and colleagues, indicates that voice analysis by a smartphone app could be used to identify lung congestion in heart failure patients, allowing early intervention before their condition deteriorates. The small study was presented HFA Discoveries, a scientific platform of the European Society [...]

2020-06-19T11:27:30+00:00June 19th, 2020|Tags: , |

Medtronic receives US FDA approval for Cobalt and Crome implantable ICDs

Cobalt ICD Medtronic has received FDA approval for its Cobalt and Crome implantable cardioverter-defibrillators (ICD) and cardiac resynchronisation therapy-defibrillators (CRT-D). ICDs monitor heart rhythms and deliver therapy to correct heart rates that are too fast and can lead to sudden cardiac arrest. CRT-Ds, a treatment option for some individuals with heart failure, [...]

2020-05-11T15:54:02+00:00May 11th, 2020|Tags: , , |

Cook Medical and Surmodics reach distribution agreement for two new vascular products

Cook Medical and Surmodics have announced an agreement in which Cook Medical will distribute two new Surmodics products, hydrophilic percutaneous transluminal angioplasty (PTA) balloon catheters that can be used over 0.014-inch and a 0.018-inch wire guides. “We have had a long relationship with Surmodics, utilising its innovative surface modification technology with many of our [...]

2020-05-11T15:49:16+00:00May 11th, 2020|Tags: , , |

Terumo Aortic announces FDA approval for Treo endovascular device

Treo stent graft Terumo Aortic has announced that the FDA has granted approval of the Treo abdominal aortic stent-graft system for sale in the USA for the treatment of patients with abdominal aortic aneurysms (AAA). According to a press release, Treo is the only device commercially available for endovascular aneurysm repair (EVAR) with dual [...]

2020-05-11T15:56:25+00:00May 11th, 2020|Tags: , , |

FDA clears Aspire MAX mechanical thrombectomy system

Aspire MAX mechanical thrombectomy system Control Medical Technology has announced that the US Food and Drug Administration (FDA) has cleared its Aspire MAX 7 – 11F mechanical thrombectomy platform to remove blood clots from peripheral vessels. “This FDA clearance quadruples our product offering and improves our ability to help patients,” said Shawn Fojtik, president [...]

2020-05-11T15:40:56+00:00May 11th, 2020|Tags: , |

Wearable necklace-ECG can detect abnormal heart rhythm

Necklace-ECG A necklace that detects abnormal heart rhythm will be showcased for the first time on EHRA Essentials 4 You, a scientific platform of the European Society of Cardiology (ESC). According to the study’s author, Elmeri Santala from the University of Eastern Finland, the wearable necklace-ECG (electrocardiogram) provides “a new and easy method for detecting [...]

2020-05-11T15:36:58+00:00May 11th, 2020|

LifeSignals receives CE mark for the ECG Remote Monitoring Patch

LifeSignal remote monitoring patch LifeSignals has received CE mark approval for the LifeSignals ECG Remote Monitoring Patch, a disposable wireless remote monitoring system, intended for use by healthcare professionals for continuous collection of Electrocardiography (ECG) and heart rate monitoring in ambulatory, hospital, healthcare and home settings. Patient data can be transmitted wirelessly [...]

2020-05-11T15:27:53+00:00May 11th, 2020|Tags: , |

CE mark for SuperSaturated oxygen therapy

TherOX DS2 ZOLL Medical has received CE Mark approval to market and distribute its SuperSaturated oxygen (SSO2) therapy system in Europe. A press release reports that SSO2 therapy provides interventional cardiologists with the first and only clinically proven treatment beyond percutaneous coronary intervention (PCI) to significantly reduce muscle damage in myocardial infarction [...]

2020-05-11T15:20:51+00:00May 11th, 2020|Tags: , , , |

Newer generations of MitraClip associated with greater reduction in mitral regurgitation than previous version

Source: BIBA MedTech Insights At the American College of Cardiology/World Congress of Cardiology’s virtual scientific sessions (ACC.20/WCC Virtual; 28–30 March, Chicago, USA), D Scott Lim (University of Virginia, Charlottesville, USA) reported that mitral regurgitation ≤1+ was achieved more frequently with MitraClipNTR or with MitraClipXTR (both Abbott) than previously observed with the first-generation [...]

2020-05-11T15:07:35+00:00May 11th, 2020|

COVID-19: Survey suggests increased operating days may be required to clear elective backlog

A BIBA MedTech Insights survey indicates that 50% of centres performing structural heart procedures believe that they will need to increase the number of operating days per week to manage the elective cases that have been put on hold because of COVID-19. However, 22% believe that no extra measures will be required and the backlog will [...]

2020-05-11T15:08:35+00:00May 11th, 2020|Tags: |

Abiomed acquires novel ECMO developer Breethe

Abiomed (maker of the Impella heart pump) has acquired Breethe, developer of a novel extracorporeal membrane oxygenation (ECMO) system. A press release reports that the acquisition will complement and expand Abiomed’s product portfolio to more comprehensively serve the needs of patients whose lungs can no longer provide sufficient oxygenation. Such patients include those with cardiogenic [...]

2020-05-01T13:18:09+00:00May 1st, 2020|Tags: , , , |

Artio Medical appoints Nathaniel Hagedorn to board of directors

Nathaniel Hagedorn Artio Medical has announced the appointment of entrepreneur and businessman Nathaniel Hagedorn to its board of directors. As the founder and CEO of NorthPoint Development, Hagedorn has raised over $6.5B in capital and brings nearly two decades of experience in accessing new markets and scaling new business opportunities. Hagedorn founded [...]

2020-05-01T12:25:25+00:00May 1st, 2020|Tags: , , |

Terumo Aortic announces US FDA breakthrough device designation for Thoraflex Hybrid device

Thoraflex Hybrid stented device Terumo Aortic today announced that the US Food and Drug Administration (FDA) has granted breakthrough device designation for its Thoraflex Hybrid stented device for complex aortic arch repair. The purpose of the FDA’s breakthrough device designation programme is to fast-track the regulatory review process for certain medical technologies and device-led [...]

2020-05-01T11:09:46+00:00May 1st, 2020|Tags: , , |

Cerus Endovascular’s 021 Contour neurovascular system approved in Europe

Cerus Endovascular has received CE mark approval for its 0.021-inch Contour neurovascular system, compatible with smaller commercially available 021 microcatheters for the treatment of saccular intracranial aneurysms. According to the company, the Contour neurovascular system is a fine mesh braid that is deployed across the neck of the aneurysm sac and provides a combination [...]

CE mark granted to the first biodegradable drug-eluting microspheres, BioPearl

Terumo Europe today announced that their BioPearl microspheres have received CE mark, providing a new option for patients eligible for locoregional embolization for the treatment of liver cancer. BioPearl microspheres are designed to preserve post-transarterial chemoembolization (TACE) target artery access, opening up the potential for cyclic treatment. Currently, drug-eluting microsphere TACE (DEM-TACE) and conventional TACE are both [...]

2020-05-06T07:56:49+00:00May 1st, 2020|Tags: , , |

FDA Breakthrough Device Designation for novel heart failure therapy

VisCardia, Inc. VisCardia has been granted Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its implantable VisONE system, which is designed for the treatment of moderate-to-severe heart failure with reduced ejection fraction and preserved ventricular synchrony. A press release reports that VisONE has now completed the first phase of the [...]

2020-05-01T10:31:34+00:00May 1st, 2020|Tags: , , , |

Boston Scientific reveals CE mark for Acurate neo 2 in Q1 financial results report

Acurate neo (first generation) Boston Scientific, according to a press release announcing the company’s Q1 2020 financial results, has received the CE mark for its Acurate neo2 aortic valve system. The press release reports that the transcatheter aortic valve implantation (TAVI) system builds on the clinical performance of the original Acurate neo [...]

2020-05-01T10:27:58+00:00May 1st, 2020|Tags: , , , |

Cardiovascular robotics company secures €40 million series C financing round

Robocath, which designs, develops and commercialises cardiovascular robotic systems for the treatment of vascular diseases, has secured €40 million ($43M) in a series C round of financing. A press release reports that this was led by MicroPort Scientific Corporation, with participation from institutional investors (Zhejiang Silk Road Fund, Luxembourg CLIIF managed under TUS-Holdings, CS [...]

2020-05-01T10:24:07+00:00May 1st, 2020|Tags: , , |

COVID-19: CMS outlines recommendations for restarting non-emergent procedures

On 18 March, the Centers for Medicare & Medicaid Services (CMS) recommended “limiting non-essential care and expanding surge capacity into ambulatory surgical centres and other areas” to conserve resources and staff for managing COVID-19 patients. However, in a statement issued on 19 April, it now said it recognises “at this time, many areas [in [...]

2020-05-01T10:21:05+00:00May 1st, 2020|Tags: |

Pi-Cardia closes a US$27 million financing round led by Sofinnova Partners

Leaflex Pi-Cardia has closed a US$27 million round of financing, led by Sofinnova Partners. A press release reports that Pi-Cardia’s Leaflex catheter performs mechanical scoring of valve calcification, restoring leaflets’ mobility and improving valve haemodynamics. The Leaflex catheter is designed to be a cost-effective, durable standalone treatment. It can be used for [...]

2020-04-22T12:38:11+00:00April 22nd, 2020|Tags: , |

Proximo Medical named as commercialisation partner for Elucid Bioimaging

Elucid Bioimaging Proximo Medical has announced a partnership with Elucid Bioimaging, a developer of diagnostic image analysis software used to assist in the detection and treatment of myocardial infarction and stroke. A press release states that Elucid Bioimaging’s signature technology, vascuCAP, is the only Food and Drug Administration (FDA)-cleared, histologically-validated software for [...]

2020-04-22T12:29:23+00:00April 22nd, 2020|Tags: , , |

COVID-19: Zimmer Biomet CEO gives up salary during pandemic

Zimmer Biomet has announced that, because of the effect of the pandemic, it estimates revenue growth for the first quarter 2020 will be approximately -9.5 to -10.5% on a reported basis and -8.5 to -9.5% on a constant currency basis when compared to the first quarter of 2019. Additionally, the company is taking several [...]

2020-04-16T15:57:38+00:00April 16th, 2020|Tags: , |

MolecuLight announces strategic alliance with Tissue Analytics

i:X MolecuLight has announced the integration of its MolecuLight i:X device with Tissue Analytics’ interconnected platform for seamless integration with leading electronic medical record (EMR)/electronic health record (EHR) platforms. According to a press release, Tissue Analytics is an artificial intelligence (AI)-powered cloud-based software solution that allows providers to monitor and automatically measure [...]

2020-04-16T15:33:00+00:00April 16th, 2020|Tags: , , |

Tim Attebery resigns as ACC, ACCF and MedAxiom CEO

Tim Attebery has resigned as CEO of the American College of Cardiology (ACC) and MedAxiom, as the result of changing personal and family priorities. The ACC Board of Trustees has selected Cathleen Gates as interim CEO for the near future.  Attebery joined the College as CEO in September 2018. During his tenure, the College [...]

2020-04-16T15:27:08+00:00April 16th, 2020|

Tack Endovascular System receives FDA approval for below-the-knee post-angioplasty dissection repair

Tack Endovascular System (4F) Intact Vascular has received FDA approval for the Tack Endovascular System (4F), a novel, minimal metal implant for precision dissection repair in the mid/distal popliteal, tibial and/or peroneal arteries. Regulatory approval was based on data from Intact Vascular’s Tack Optimised Balloon Angioplasty II BTK (TOBA II BTK) clinical [...]

2020-04-16T15:20:44+00:00April 16th, 2020|Tags: , , |

Axonics wins FDA approval for its next-generation implantable neurostimulator

Axonics has announced the FDA approval of its next-generation rechargeable implantable neurostimulator for its r-SNM system under a premarket approval (PMA) supplement. This next-generation implantable neurostimulator decreases how frequently a patient needs to recharge their implanted device to once a month for about one hour. This compares to the current recharging interval which is [...]

2020-04-16T14:43:49+00:00April 16th, 2020|Tags: , |

COVID-19: Stryker develops Emergency Relief Bed in response to pandemic

Stryker’s Emergency Relief Bed, a limited-release medical bed, supports critical needs during COVID-19 pandemic. Stryker has announced the development of a limited-release emergency response bed to quickly aid healthcare providers with efficient care during the COVID-19 pandemic. The Emergency Relief Bed is a low-cost solution intended to serve frontline healthcare providers. It includes a [...]

2020-04-16T14:40:32+00:00April 16th, 2020|Tags: , |

First patient enrolled globally in SELUTION SLR study for AV fistulae

Selution SLR MedAlliance has announced enrolment of the first patient in the SAVE (Use of the Selution sirolimus-eluting balloon for dysfunctional AV access treatment indications) study utilising their novel sirolimus-eluting balloon, for the treatment of failed arteriovenous (AV) fistulae in renal dialysis patients. The objectives of this prospective, randomised, single-blind multicentre study [...]

2020-04-16T13:42:19+00:00April 16th, 2020|Tags: , , |

COVID-19: FDA authorise blood purification device for treating virus

The US Food and Drug Administration (FDA) issued an emergency use authorisation for a blood purification system (Spectra Optia Apheresis System, Terumo BCT) combined with Adsorption Cartridge (Marker Therapeutics) to treat patients 18 years of age or older with confirmed COVID-19 admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure. A [...]

2020-04-16T13:35:58+00:00April 16th, 2020|Tags: , , |

COVID-19: Nearly 40% drop in STEMI cases in US cath labs since March 2020

Santiago Garcia Santiago Garcia (Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, USA) and colleagues report in the Journal of American College of Cardiology that there was a 38% drop in cath lab ST-segment elevation myocardial infarction (STEMI) activations in the USA after the COVID-19 pandemic started to substantially affect US social life and [...]

2020-04-16T13:23:05+00:00April 16th, 2020|Tags: , |

Shockwave completes enrolment in study of coronary intravascular lithotripsy

Shockwave Medical has completed enrolment in its US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study—DISRUPT CAD III—for the use of intravascular lithotripsy (IVL) for the management of heavily calcified coronary arteries. A press release reports that the investigational Shockwave IVL system with the Shockwave C2 Coronary IVL catheter, which has been [...]

2020-04-08T16:04:21+00:00April 8th, 2020|Tags: , , |

Virtual ACC: More positive data for Medtronic’s renal denervation system

Symplicity Spyral Data published in the Lancet—and simultaneously presented at the American College of Cardiology together with World Congress of Cardiology Scientific Sessions (ACC.20/WCC) virtual meeting (28–30 March, Central Time)—provide further evidence that renal denervation with the Symplicity Spyral (Medtronic) catheter is an effective approach for lowering blood pressure in patients who [...]

2020-04-07T12:38:17+00:00April 7th, 2020|Tags: , , , , |

COVID-19: Edwards pauses enrolment in mitral and tricuspid trials to allow hospitals to focus on virus

Edwards Lifesciences has temporarily paused new enrolments in its active pivotal clinical trials of its transcatheter mitral and tricuspid therapies in response to ongoing COVID-19 pandemic. A press release reports that the company is coordinating closely with the trials’ clinical investigators at the relevant hospital. It adds that the decision to resume enrolments in [...]

2020-04-06T11:21:43+00:00April 6th, 2020|Tags: , , |

COVID-19: BD, BioMedomics launch of rapid serology test to detect exposure to virus

BD and BioMedomics have announced the release of a new point-of-care test that can detect antibodies in blood to confirm current or past exposure to COVID-19 in as little as 15 minutes. A press release states that the new test, developed and manufactured by BioMedomics, will be available through BD—and distributed exclusively by Henry [...]

2020-04-06T10:16:02+00:00April 6th, 2020|Tags: , |

OrthoPediatrics buys ApiFix Ltd, developer of FDA-approved non-fusion scoliosis technology

OrthoPediatrics has acquired ApiFix, including its minimally invasive deformity correction (MID-C) system for non-fusion treatment of progressive adolescent idiopathic scoliosis, for 934,768 shares of OrthoPediatrics common stock and US$2 million in cash paid at closing, plus milestone payments and an earnout over a period of four years. A press release reports that ApiFix is [...]

2020-04-06T10:07:53+00:00April 6th, 2020|Tags: , , , |

Mardil Medical completes treatment of third patient in VenTouch device trial

Mardil Medical has announced the successful completion of treatment for the third patient in the clinical trial of its improved VenTouch device for type IIIb functional mitral valve regurgitation. A press release reports that the device is a combination therapy which simultaneously treats the distorted valve, the dilated ventricle and the displaced papillary muscles. [...]

2020-04-06T10:02:12+00:00April 6th, 2020|Tags: , |

COVID-19: CMSS “strongly urges action” to ensure all frontline healthcare professionals are protected

In a new statement published on 2 April 2020, all 45 societies represented by the US Council of Medical Specialty Societies (CMSS)—over 800,000 physicians—emphatically declare their belief that all frontline healthcare professionals must have access to personal protective equipment (PPE) and be able to speak publicly about the lack of PPE without retribution while pushing for [...]

2020-04-03T16:23:27+00:00April 3rd, 2020|Tags: |

COVID-19 FDA grant Abbott emergency use authorisation to launch test for novel coronavirus

COVID-19 Abbott has announced that the FDA has issued Emergency Use Authorisation (EUA) for the its molecular test for COVID-19. According to a press release, Abbott is immediately shipping 150,000 Abbott RealTime SARS-CoV-2 EUA tests to existing customers in the USA. The tests are used on the company’s m2000 RealTime System. The [...]

2020-04-02T16:43:54+00:00April 2nd, 2020|Tags: , , |

COVID-19: Medtronic shares ventilation design specs to speed up global production

Medtronic is publicly sharing the design specifications for the Puritan Bennett 560 (PB 560) to enable participants across industries to evaluate options for rapid ventilator manufacturing to help efforts to manage patients with COVID-19. A press release reports that this this decision is consistent with the recent FDA Guidance and in accordance with the [...]

2020-04-02T16:32:54+00:00April 2nd, 2020|Tags: , |

COVID-19: Boston Scientific takes steps to mitigate impact of pandemic

Boston Scientific has revealed that its assuming the Q2 2020 impact of COVID-19 will be more significant than that of Q1 2020. As a result, the company is “taking proactive steps to reduce costs and be in a strong position to support customers and patients when healthcare systems begin to recover, and elective procedures [...]

2020-04-02T16:24:12+00:00April 2nd, 2020|Tags: , , |

Virtual ACC: Positive data for Medtronic’s Evolut TAVI system in low-risk patients with bicuspid aortic valve stenosis

Late-breaking data presented at the American College of Cardiology together with World Congress of Cardiology Scientific Sessions (ACC.20/WCC) virtual meeting (28–30 March, Central Time) show that transcatheter aortic valve implantation (TAVI) with the Evolut device (Medtronic) in low-risk patients with bicuspid aortic valves is associated with low rates of all-cause mortality or stroke at [...]

2020-04-02T11:56:58+00:00April 2nd, 2020|Tags: , , , |

FDA approve TherOx system for reducing heart damage in “widowmaker” myocardial infarction patients

TherOX DS2 Zoll has received FDA approval of the second-generation TherOx system, which—a press release reports—provides super-saturated oxygen (SSO2) therapy. SSO2 therapy is designed to deliver hyperbaric levels of oxygen directly to the damaged heart muscle immediately after successful revascularisation via angioplasty and stenting of the blocked coronary artery. The press release [...]

2020-04-01T16:41:47+00:00April 1st, 2020|Tags: , , |

MolecuLight to participate in virtual WoundCon 2020

MolecuLight is to sponsor and participate in the virtual exhibit of WoundCon Spring 2020—a one-day conference and exhibition to be held on 2 April 2020.  According to a press release, WoundCon has become the largest conference for wound care, with more than 10,000 wound care professionals registered for the one-day clinical conference and virtual exhibition. [...]

2020-04-01T16:34:09+00:00April 1st, 2020|Tags: , , |

New smartwatch app can monitor heart rhythms during sleep

FibriCheck, a CE-mark and FDA-approved medical app, has launched the first smartwatch app that automatically monitors users’ heart rhythms during their sleep. The app, which can be integrated into any brand of smartwatch, detects episodes of both intermittent and silent atrial fibrillation. A press release reports that FibriCheck’s latest innovation offers an easy and [...]

2020-04-01T16:27:27+00:00April 1st, 2020|Tags: |

COVID-19: Doctor in the house call for volunteers to provide remote consultations during pandemic

A new website—www.doctorinthehouse.net—is calling for healthcare professionals to volunteer for its free virtual consultation service. The aim of the service, according to a press release, is to ease the pressure on the NHS during the COVID-19 outbreak by giving patients first-hand, remote, consultations while the UK is on lockdown. The press release states that [...]

2020-04-01T16:14:31+00:00April 1st, 2020|Tags: , |

COVID-19: CX 2020 is cancelled due to virus

The 2020 Charing Cross (CX) Symposium that was due to take place next month in London, UK, has been cancelled due to COVID-19.  In full, the statement from the CX Symposium team, reads: “The CX Symposium team has made the difficult but necessary decision to cancel the Charing Cross Symposium 2020 that was scheduled to take [...]

2020-04-01T14:53:24+00:00April 1st, 2020|Tags: , |

NICE aortic guidelines recommend discussion between physician and patient before offering any treatment

The UK National Institute for Health and Care Excellence (NICE) has published guidelines on abdominal aortic aneurysm (AAA) diagnosis and management. Discussion between physicians and patients to consider the risks of any intervention versus no intervention is encouraged, and, while the guidelines are in favour of open repair for most patients, they also highlight [...]

2020-04-01T14:47:43+00:00April 1st, 2020|Tags: , |

COVID-19: New project to explore printing 3D ventilator parts and masks

Aram Saeed (School of Pharmacy, University of East Anglia [UAE], Norwich, UK) and others have launched a project to 3D print ventilator parts, masks and other critical equipment to manage the COVID-19 virus. According to a press release, they are working with the tech community to access 3D printers, as well people with the [...]

2020-03-30T11:03:03+00:00March 30th, 2020|Tags: |

COVID-19: Adapt clinical studies to alleviate effect of pandemic

Mary M McDermott A viewpoint in the Journal of the American Medical Association (JAMA) has offered potential solutions to modifying ongoing randomised clinical trials during the COVID-19 pandemic. It aims to “minimise disruption and preserve integrity”, while still ensuring participant health and safety. Authors Mary M McDermott (deputy editor of JAMA, and [...]

2020-03-30T10:57:03+00:00March 30th, 2020|Tags: |

COVID-19: PRA Health Sciences expands remote clinical study support with its Mobile Health Platform

As a response to the ongoing global COVID-19 pandemic, PRA Health Sciences has announced the expansion of its Mobile Health Platform for remote clinical monitoring, adding several new capabilities that address sponsor needs for COVID-19 virtual study support. A press release states that the Mobile Health Platform (MHP) engages with patients wherever they are. [...]

2020-03-30T10:30:03+00:00March 30th, 2020|Tags: , , |

COVID-19: New FDA guidance allows use of KardiaMobile 6L to measure QTc in virus patients

Kardia 6L AliveCor’s KardiaMobile 6L—the world’s only six lead personal ECG—is now allowed for use in the measurement of a patient’s QTc and detection of potentially dangerous QT prolongation.  A prolonged QTc can lead to a potentially fatal side effect, which is associated with the use of several medicines now being used [...]

2020-03-30T10:19:17+00:00March 30th, 2020|Tags: , , |

COVID-19: European Commission looking to postpone new MDR by one year

During a Q&A section of a European Commission (EC) college meeting on 25 March, EC spokesperson Stefan de Keersmaecker stated that the commission were looking to delay the “entry into force” of the new European medical device regulations (MDR) because of the global coronavirus pandemic. de Keersmaecker, who spoke via video, said: “The EC [...]

2020-03-27T17:28:57+00:00March 27th, 2020|Tags: , |

Approvals & refusals—February 2020

In February, Abbott received FDA Breakthrough Device Designation for a fully implantable left ventricular assist device, Biotronik received the CE mark for its Osiro Mission drug-eluting stent, and BlueGrass Vascular Technologies got a FDA de novo classification order for its Surfacer Inside-Out access catheter system. CE marks CE mark—Fist compression device (Fist Assist Devices) [...]

2020-03-05T12:19:16+00:00March 5th, 2020|Tags: |

HydroPICC central catheter from Access Vascular receives FDA clearance

Hero Access Vascular has announced that it has received clearance from the FDA for the second generation of its HydroPICC peripherally inserted central catheter (PICC), which has demonstrated a thrombus accumulation rate 30 times less than traditional PICCs and the potential to significantly reduce catheter occlusions. PICCs have become an increasingly popular [...]

2020-03-05T11:19:12+00:00March 5th, 2020|Tags: , , , |

ATEC agrees to acquire EOS imaging

EOSedge Alphatec Holdings (ATEC) has announced that it has entered into an agreement to acquire EOS imaging for a purchase price of up to US$88 million, plus debt retirement of US$33.9 million, in a combination of cash and equity. EOS imaging is specialist in orthopaedic medical imaging and software solutions. The EOS technology [...]

2020-03-05T11:09:44+00:00March 5th, 2020|Tags: , , , |

Veterans study suggests surgery is still dominant revascularisation approach for critical limb ischaemia

Saket Girotra A review of data from Veteran Health Administration shows that there was a temporal increase in the use of revascularisations for the management of critical limb ischaemia between 2005 and 2014. This increase correlated with a reduction in both mortality and major amputation during the same time period. However, contrary [...]

2020-03-05T10:11:41+00:00March 5th, 2020|

Heart Research UK gives University of Leeds a grant to develop new treatments for heart failure

Scott Bowen A research project at the University of Leeds aiming to identify new drug treatments for heart failure patients has been awarded a grant of almost £150,000 by British charity Heart Research UK.  The project, which will be led by Scott Bowen (University of Leeds, UK), will investigate the causes of [...]

2020-02-27T13:32:48+00:00February 27th, 2020|Tags: , |

Fist Assist Devices announces CE mark for its compression device

Fist Assist Devices has received the CE mark and has begun marketing the Fist Assist device for vein enhancement and enlargement in the European Union and other countries that recognise the CE mark. According to the press release, Fist Assist is the only wearable, patent-protected, intermittent compression device to increase vein diameter prior to [...]

2020-02-27T13:26:21+00:00February 27th, 2020|Tags: , , |

First patients enrolled in PROACTIVE-HF trial of Cordella pulmonary artery pressure sensor system

Cordella Endotronix has announced the enrolment of the first two patients in the PROACTIVE-HF trial. The trial is a premarket investigational device exempt (IDE) study evaluating the safety and efficacy of the Cordella pulmonary artery pressure sensor system (Cordella sensor) for the treatment of heart failure. The first two patients were successfully [...]

2020-02-27T13:19:12+00:00February 27th, 2020|Tags: , , |

Gregg Stone announced as co-principal investigator of ALIVE trial of Revivent TC system for heart failure

BioVentrix BioVentrix has announced that Gregg Stone (Mount Sinai Health System, New York, USA) has signed on as principal investigator of the ALIVE trial of the Revivent TC transcatheter ventricular enhancement system. The system is a hybrid, closed-chest transcatheter procedure designed to treat patients with ischaemic cardiomyopathy by reshaping and restoring the [...]

2020-02-27T13:13:14+00:00February 27th, 2020|Tags: , , |

FDA Breakthrough Device Designation for Cardiovalve tricuspid valve replacement system

Cardiovalve has received FDA approval for an early feasibility study of its transcatheter tricuspid valve replacement system for a tricuspid regurgitation indication; the Cardiovalve system also has been granted Breakthrough Device Designation status by the FDA. Cardiovalve commenced its study for tricuspid regurgitation in the USA earlier this year. The study’s primary endpoint is [...]

2020-02-27T13:07:05+00:00February 27th, 2020|Tags: , |

Proof-of-concept data for safety of Appligator left atrial appendage closure system

Appligator Append Medical has announced the clinical proof-of-concept data evaluating the safety of left atrial appendage (LAA) closure through Append’s patented tissue manipulation procedure. A press release says that the procedure serves as a feasibility study for Append’s Appligator minimally invasive LAA closure device, which uses natural tissue manipulation to achieve complete [...]

2020-02-27T13:01:23+00:00February 27th, 2020|Tags: , |

FDA clearance for SuperMap high-resolution mapping algorithm

SuperMap (Acutus Medical) Acutus Medical has announced FDA clearance of SuperMap, which a press release calls a revolutionary addition to the company’s AcQMap 3D imaging and mapping system. It adds that SuperMap is a high-fidelity, high-resolution mapping algorithm for both stable and transient arrhythmias. Furthermore, SuperMap’s user interface effortlessly guides electrophysiologists to [...]

2020-02-27T16:55:42+00:00February 27th, 2020|Tags: , , |

CE mark for Abbott’s Gallant CRT-D and ICD

Gallant Abbott has received the CE mark for the new Gallant implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) devices, which—a press release reports—have the most advanced heart rhythm management capabilities along with a new set of benefits to people in Europe with abnormal heart rhythms and heart failure. The [...]

2020-02-27T12:45:36+00:00February 27th, 2020|Tags: , |

Medtronic acquires UK company Digital Surgery

Medtronic has announced its acquisition of Digital Surgery, which is a privately-held pioneer in surgical artificial intelligence (AI), data and analytics, and digital education and training. A press release says that the acquisition will strengthen the Medtronic robotic-assisted surgery platform and has applicability for the Medtronic broader portfolio. The terms of the agreement have [...]

2020-02-17T13:49:00+00:00February 17th, 2020|Tags: , , , |

Rexgenero appoints Huw Jones as a non-executive director

Huw Jones Rexgenero has announced that Huw Jones has joined the company’s board as a non-executive director, and will chair the company’s remuneration committee. This follows the recent appointment of David Horn Solomon as chairman of Rexgenero’s Board. Huw is currently CEO of Chronos Therapeutics Limited (Chronos), a spin out from the [...]

2020-02-17T13:39:13+00:00February 17th, 2020|Tags: , |

CorWave appoints Jim Schuermann as an independent director

CorWave, a medtech company focused on the development of an innovative left ventricular assist device (LVAD), has announced today the election of Jim Schuermann to its board of directors. A press release states that Schuermann was instrumental in transforming HeartWare—a LVAD start-up valued around $100M when he joined—into a $Bn Nasdaq-listed company. As senior [...]

2020-02-17T13:33:23+00:00February 17th, 2020|Tags: , , |

FDA grants de novo clearance to Bluegrass Vascular Technologies for the Surfacer Inside-Out access catheter system

Bluegrass Vascular Technologies (BVT) has announced that the FDA has granted a de novo classification order for its Surfacer Inside-Out access catheter system. A press release reports that the Surfacer system is intended to obtain central venous access to facilitate catheter insertion into the central venous system for patients with upper body venous occlusions [...]

ACC forms alliance with HeartHero

HeartHero The American College of Cardiology (ACC) and HeartHero have formed an alliance to make a significant impact on survival rates after sudden cardiac arrest and further ACC’s mission to transform cardiovascular care and improve heart health through HeartHero’s portable automated external defibrillator (AED) technology. While ACC is involved in other innovation [...]

2020-02-17T13:19:37+00:00February 17th, 2020|Tags: , |

Metactive Medical changes name to “Artio Medical”

Metactive Medical has changed its name to Artio Medical, effective immediately. Artio Medical was founded in 2014 as a small research and development group focused on developing metal implants for vascular embolisation. The organisation has since grown to include a team, according to a press release, of exceptionally talented medical device professionals and expanded [...]

2020-02-17T13:13:26+00:00February 17th, 2020|Tags: , |

Xeltis paediatric pulmonary valve shows promise

Xeltis valve A press release reports that clinical trial results of Xeltis pulmonary valve show promising functionality of the living valves, which is developed in patients as a result of its restorative implants. The data were presented at the International Conference of Tissue-Engineered Heart Valves (ICTEHV) as part of the 2020 Heart [...]

2020-02-17T13:09:46+00:00February 17th, 2020|Tags: , |

Orsiro Mission receives CE mark

Orsiro Mission Biotronik now has the CE mark for its Orsiro Mission drug-eluting stent system. According to a press release, the next-generation of the company’s ultrathin strut Orsiro drug-eluting stent provides higher deliverability than other contemporary stents. The press release states that the Orsiro Mission “has a completely re-engineered delivery system to [...]

2020-02-17T12:59:36+00:00February 17th, 2020|Tags: , , |

FDA grants Caption Health authorisation for first AI-guided image acquisition system

Caption guidance Caption Health has announced that the FDA has authorised marketing of Caption Guidance software, which is designed to assist medical professionals in the acquisition of cardiac ultrasound images. The system uses artificial intelligence (AI) to provide real-time guidance and diagnostic quality assessment of images. The aim is to empower healthcare [...]

2020-02-10T17:58:02+00:00February 10th, 2020|Tags: , , , |

XableCath crossing catheters have received CE mark for peripheral use

XableCath has announced that its XableCath Crossing catheters have received CE mark for peripheral use. Its crossing devices will be available for sale in Europe in two versions, a blunt tip and an abrasion tip, in a variety of diameters and lengths. XableCath received US Food and Drug Administration (FDA) clearance for its crossing [...]

2020-02-10T14:44:43+00:00February 10th, 2020|Tags: , |

Medtronic starts new pilot study of its Symplicity Spyral renal hypertension system

Medtronic has said it will begin enrolment in a pilot study evaluating the safety and efficacy of the Symplicity Spyral renal denervation system using a targeted procedural approach with a reduced number of radio frequency ablations. Set to enrol 50 patients at up to 15 sites in the USA and Europe, the single-arm study [...]

2020-02-10T13:56:26+00:00February 10th, 2020|Tags: , , , |

Enrolment completed in US trial of VasQ external support

Laminate Medical Technologies has announced the completion of enrolment into the VasQ External Support US study.  The study was conducted at 17 sites across the USA and prospectively enrolled 144 male and female patients in need of an arteriovenous fistula (AVF) for haemodialysis. Both brachiocephalic and radiocephalic AVF patients were included in the study. [...]

2020-02-10T13:49:41+00:00February 10th, 2020|Tags: , , |

FDA Breakthrough Designation for device for treating pulmonary arterial hypertension

The FDA has granted Breakthrough Device Designation for the Aria CV pulmonary hypertension system (Aria CV PH System). A press release reports that Aria has already performed a successful acute first- in-human clinical study in Vienna, Austria, and is now preparing for a US clinical trial under the FDA’s early feasibility study programme to [...]

2020-02-10T13:29:44+00:00February 10th, 2020|Tags: , , , |

FDA Breakthrough Device Designation for fully implantable left ventricular assist system

Robert Kormos The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Abbott for its in-development fully implantable left ventricular assist system (FILVAS). The FDA Breakthrough Device Designation programme will allow, according to Robert L Kormos (medical director for mechanical circulatory support at Abbott), the company to “fast track” [...]

2020-02-05T14:10:54+00:00February 5th, 2020|Tags: , , , |

Rhythm AI to work with Biosense Webster on STAR Mapping clinical trial

Rhythm AI has announced the signing of a research collaboration agreement with Biosense Webster. A press release outlines that the agreement grants Rhythm AI access to certain data from the Biosense Webster CARTO 3 system to support a multicentre clinical trial of its STAR Mapping system. STAR Mapping is a new, AI driven mapping [...]

2020-02-05T13:15:09+00:00February 5th, 2020|Tags: , , , |

Heart Research UK fund study evaluating method of growing blood vessels

The charity Heart Research UK is donating more than £100,000 to a project, led by Paolo Madeddu (chair of Experimental Cardiovascular Medicine, the University of Bristol, Bristol, UK), that is developing a new treatment, BACH1 inhibitors, for stimulating the growth of new blood vessels in the heart. Paolo Madeddu et al previously found that [...]

2020-02-05T13:04:00+00:00February 5th, 2020|Tags: |

Selution SLR receives CE mark for endovascular applications

MedAlliance has announced that it now has the CE mark for the Selution SLR—a sirolimus drug-eluting balloon for the treatment of peripheral arterial disease. This approval applies to sizes from 2x20mm to 7x150mm. According to a press release, this award was supported by two-year results from the SELUTION SLR first-in-human study, which involved 50 [...]

2020-02-05T12:54:47+00:00February 5th, 2020|Tags: , , |

Biolitec adds new laser fibre for severely tortuous veins to its portfolio

ELVes Radial 2ring Pro fibre Biolitec has added another laser fibre to its ELVeS Radial 2ring laser fibre portfolio. A press release reports that the newly developed ELVeS Radial 2ring Pro enables the minimally invasive endovenous laser treatment of severely tortuous veins. It adds that the ELVeS Radial 2ring Pro fibre has [...]

2020-02-05T12:49:04+00:00February 5th, 2020|Tags: , , |

CE mark for Cobalt for Crome portfolio of ICDs and CRT-Ds

Cobalt ICD Medtronic has received the CE mark for its Cobalt and Crome portfolio of implantable cardioverter-defibrillators (ICD) and cardiac resynchronisation therapy-defibrillators (CRT-D). With the launch of the Cobalt and Crome platform, Medtronic also is making TriageHF technology available. A press release reports that this technology assesses patients’ heart failure risk through [...]

2020-02-05T12:40:29+00:00February 5th, 2020|Tags: , , , |

FDA approves expanded enrolment of study evaluating novel heart failure device

AccuCinch The FDA has approved an expansion of enrolment of the CorCinch HFrEF early feasibility study, which is evaluating the AccuCinch ventricular repair system (Ancora Heart) for the management of patients with reduced ejection fraction heart failure (HFrEF). This expansion allows Ancora Heart to double patient enrolment from 15 to 30 patients and [...]

2020-02-05T12:34:19+00:00February 5th, 2020|Tags: , , |

Admedus finalises license and associated milestone payment with 4C Medical

Admedus has announced the complete transfer of its sterilisation method as part of its Adapt tissue treatment process to 4C Medical. As per the Admedus supply agreement with 4C Medical, 4C Medical will pay an additional $US1 Million ($US 0.44M previously received) to use the technology to sterilise the Adapt tissue incorporated in its transcatheter [...]

2020-02-05T12:30:37+00:00February 5th, 2020|Tags: , , , |

CACVS 2020: Artificial intelligence system shows promise for measuring aneurysms after EVAR

Stéphan Haulon At the 2020 Controversies and Updates in Vascular Surgery meeting (CACVS; 23–25 January, Paris, France), Stéphan Haulon (Hôpital Marie Lannelongue, Groupe Hospitalier Paris Saint Joseph; Université Paris Saclay, Paris, France) reported that an artificial intelligence (AI) based system for aortic diameter and volume assessment (ARVA, Incepto Medical) had a preliminary [...]

2020-01-31T13:36:04+00:00January 31st, 2020|Tags: , |

Vascular Therapies complete upsized $17.3m private financing

Vascular Therapies has announced the closing of an upsized $17.3 million private financing. A press release reports that the financing comprised existing and new investors, and was increased from an originally targeted $15 million up to $17.3 million—based upon interest from new investors, including a strategic foreign healthcare company. It adds that Vascular Therapies [...]

2020-01-31T10:05:33+00:00January 31st, 2020|Tags: , , |

Abbott becomes first company in world to have transcatheter mitral implantation device on the market

The Tendyne transcatheter mitral valve implantation (TMVI) system (Abbott) has received the CE mark, making Abbott the first company to have such a device on a market anywhere in the world. A press release reports that this “life-changing” therapy treats significant mitral regurgitation in patients requiring a heart valve replacement and provides a safe [...]

2020-01-31T10:46:16+00:00January 30th, 2020|Tags: , , |

Approvals & refusals—January 2020

This month, Medtronic has received FDA approval for its Micra AV system and for its Stealth Autoguide system. Also, the FDA gave the company the nod to proceed with an investigational device exemption (IDE) trial to evaluate a pulsed field ablation (PFA) system. Other approvals in January include a FDA green light for a [...]

2020-01-30T15:14:23+00:00January 30th, 2020|Tags: |

FDA approve first AI-powered stethoscope for screening serious heart conditions

A press release reports that the FDA has cleared a suite of algorithms that, when combined with Eko’s digital stethoscopes, will enable healthcare providers in the USA to more accurately screen for heart conditions during routine physical exams. If left undiagnosed, these heart conditions can lead to stroke and heart failure. According to the [...]

2020-01-30T12:43:47+00:00January 30th, 2020|Tags: , , |

AF Symposium 2020: Myocardial specificity of pulsed field ablation provides safety advantage for persistent AF

Vivek Reddy At the AF Symposium 2020 (23–25 January, Washington, DC, USA), Vivek Y Reddy (Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, New York, USA) reported that pulsed field ablation (PFA)—with the Farawave (Farapulse Inc.) catheter—may be a feasible and safe approach for treating patients with persistent atrial fibrillation [...]

2020-01-31T09:37:07+00:00January 30th, 2020|Tags: , , , |

Vesalius Cardiovascular completes animal study of percutaneous mitral regurgitation device

Vesalius Cardiovascular has announced the successful completion of its first 30-day chronic animal study using its mitral valve repair device. The predetermined endpoints of the study were the absence of device or valve thrombosis and the absence of leaflet injury due to the device, and both endpoints were robustly confirmed upon completion of the [...]

2020-01-28T18:54:44+00:00January 28th, 2020|Tags: |

David Hayes appointed as chief medical officer of Biotronik

David Hayes Biotronik has announced the appointment of David Hayes as chief medical officer. A press release reports that Hayes will oversee the development of the company’s cardiovascular solutions with a focus on advancing unique, proven innovations that help physicians and health systems deliver on their commitment to patient care. The press [...]

2020-02-03T10:03:58+00:00January 28th, 2020|Tags: , |

UK heart charity reveals shortlist for £30m research prize

Nilesh Samani UK charity The British Heart Foundation (BHF) has announced its shortlist of four research projects competing for its Big Beat Challenge; a global competition, launched in August 2018, that is offering a single research award of up to £30m. The aim of the competition is to push the international research [...]

2020-01-28T18:41:56+00:00January 28th, 2020|Tags: |

Extended CE mark for Revivent TC less invasive ventricular enhancement therapy

BioVentrix BioVentrix has received an extension of its CE mark for the Revivent TC transcatheter ventricular enhancement system to May 2024. The company received its initial CE mark in 2016. Less invasive ventricular enhancement (LIVE) therapy uses the Revivent TC system to exclude scar tissue on the left ventricle that has occurred [...]

2020-01-28T18:28:17+00:00January 28th, 2020|Tags: , , |

Teleflex receives FDA clearance for Wattson temporary pacing guidewire

Teleflex has received 510(k) clearance from the FDA for its Wattson temporary pacing guidewire. A press release reports that this is the first commercially available bipolar temporary pacing guidewire designed specifically for use during transcatheter aortic valve implantation (TAVI) and balloon aortic valvuloplasty. It adds that this “innovative device” offers clinicians a 0.035” pigtailed [...]

2020-01-28T18:25:16+00:00January 28th, 2020|Tags: , , |

FDA approve Micra AV for the management of atrioventricular block

Medtronic has received FDA approval of Micra AV, which a press release describes as “the world’s smallest pacemaker with atrioventricular (AV) synchrony”; the pacemaker is indicated for the treatment of patients with AV block. The press release states that Medtronic “now offers the first and only FDA-approved leadless pacemaker portfolio, expanding the number of [...]

2020-01-28T18:20:37+00:00January 28th, 2020|Tags: , , |

First patient enrolled in study evaluating use of FEops HEARTguide in planning LAA closure procedures

FEops has announced that the first patient has been enrolled in the physician-initiated PREDICT-LAA trial. The trial, which is led by Righshospitalet (Copenhagen, Denmark), aims to assess whether the use of FEops HEARTguide computer simulations (based on cardiac CT imaging) can contribute to better preprocedural planning and improved procedural outcomes of percutaneous left atrial appendage [...]

2020-01-28T18:15:42+00:00January 21st, 2020|Tags: , , |

Opsens receives FDA approval of OptoWire III

Opsens has received 510(k) clearance from the FDA to market its OptoWire III, a coronary pressure guidewire for physiological measurements such as fractional flow reserve and diastolic pressure ratio (dPR). According to a press release, the OptoWire III is the latest version of OptoWire and the OptoWire family of products are used to diagnose [...]

2020-01-21T14:20:24+00:00January 21st, 2020|Tags: , , |

FDA clearance for BioCardia’s Morph DNA deflectable guide catheter

Morph DNA BioCardia has announced that the FDA has granted 510(k) clearance for the Morph DNA deflectable guide catheter, which is used to guide the Helix biotherapeutic delivery system during CardiAMP cell therapy delivery in the heart. The Morph DNA deflectable guide catheter, a press release reports, is designed to enhance procedural [...]

2020-01-21T14:11:06+00:00January 21st, 2020|Tags: , , , |

Wearable technology could be used to track flu-like illnesses

Jennifer Radin A study in The Lancet suggests that de-identified data from activity and physiological trackers (such as a Fitbit) could be used to provide information on flu outbreaks. Authors Jennifer M Radin (Translational Institute, Scripps Research, La Jolla, USA) and others explain that this information “could be vita to enact timely [...]

2020-01-21T12:41:43+00:00January 21st, 2020|Tags: , |

AI system shows promise for improving accuracy and efficiency of breast cancer screening

A yellow box indicates where an AI system found cancer hiding inside breast tissue (NorthWestern University) Scott Mayer Mckinney (Google Health, Palo Alto, USA) and colleagues report in Nature that an artificial intelligence (AI) system was superior to human experts in predicting breast cancer (based on mammograms). They add that the findings [...]

2020-01-15T15:50:11+00:00January 15th, 2020|Tags: , |

Cagent Vascular initiates enrolment of PRELUDE-BTK study using Serranator device

Cagent Vascular has announced the initiation of the PRELUDE-BTK study. According to a press release, the purpose of this prospective, single-arm, multicentre feasibility study is to show the safety and efficacy of the Serranator percutaneous transluminal angioplasty (PTA) serration balloon catheter in infrapopliteal arteries. Andrew Holden (University of Auckland, Auckland Hospital, Auckland, New Zealand) [...]

2020-01-15T15:40:29+00:00January 15th, 2020|Tags: , , |

FDA Breakthrough Device Designation for Selution SLR in arteriovenous fistulae

MedAlliance has now been granted FDA Breakthrough Device Designation status for its Selution sustained limus release (SLR) sirolimus-eluting balloon for an arteriovenous fistulae indication. The company has previously received similar status for the coronary in-stent restenosis and peripheral below-the-knee indications of the balloon. According to a press release, Selution’s technology involves unique micro-reservoirs made [...]

2020-01-15T15:36:52+00:00January 15th, 2020|Tags: , , |

Medtronic acquires pioneer of a novel spinal cord stimulation waveform

Intellis Medtronic has acquired Stimgenics, which a press release reports has pioneered a novel spinal cord stimulation (SCS) waveform known as “differential target multiplexed” (DTM) spinal cord stimulation. The press release adds that the therapy, which is delivered via the Medtronic Intellis platform, is a new and unique programming option to treat [...]

2020-01-15T15:26:39+00:00January 15th, 2020|Tags: , , , |

FDA approve less invasive technique with HeartMate 3 LVAD

The FDA has approved a new alternative surgical technique for the HeartMate 3 heart pump (Abbott) that will allow more advanced heart failure patients to avoid open heart surgery. The new, less invasive approach is designed to provide surgeons a choice in surgical method for patients receiving the HeartMate 3 left ventricular assist device [...]

2020-01-15T15:22:23+00:00January 15th, 2020|Tags: , , |

FDA PMA approval for WEB aneurysm embolisation system

WEB aneurysm embolisation system MicroVention (Terumo) has received FDA premarket approval (PMA) for the WEB aneurysm embolisation system for the treatment of intracranial wide neck bifurcation aneurysms. A press release states that the WEB system is the first and only PMA-approved device in the new category of intrasaccular flow disruptors for aneurysm [...]

2020-01-15T15:19:03+00:00January 15th, 2020|Tags: , , , |

Titan Medical and Cambridge design partnership announce expanded engagement for robotic instrument development

Titan Medical and Cambridge Design Partnership (CDP) has announced an expanded engagement in respect of the instrument development programme for Titan’s single-port robotic surgical system. Additionally, CDP has subscribed for common shares of Titan. David McNally, president and CEO of Titan, says: “We are pleased to announce our expanded engagement of CDP, and welcome [...]

2020-01-15T15:11:00+00:00January 15th, 2020|Tags: , , |

TriSalus Life Sciences launches TriNav infusion system

TriNav TriSalus Life Sciences has launched its TriNav infusion system (TriNav). Powered by its proprietary pressure-enabled drug delivery (PEDD) approach with SmartValve technology, according to a press release, TriNav is designed to help overcome the infusion barriers that limit therapeutic uptake in solid tumours, including hepatocellular carcinoma and liver metastases. The press [...]

2020-01-15T15:05:32+00:00January 15th, 2020|Tags: , , , |

JenaValve TAVI system designated by FDA as “Breakthrough Device”

JenaValve   JenaValve Technology has received “Breakthrough Device” designation from the FDA. This designation is for severe aortic regurgitation (AR) and AR-dominant mixed aortic valve disease. The company is the sponsor of a US investigational device exemption (IDE) trial and is conducting a multicentre clinical programme for the treatment of patients with [...]

2020-01-15T15:00:34+00:00January 15th, 2020|Tags: , |

New trial will evaluate safety and efficacy of MitraClip for mitral regurgitation in moderate-risk patients

MitraClip XTR The FDA has approved a first-of-its-kind clinical trial that will compare the effectiveness of Abbott’s minimally invasive MitraClip device with open heart mitral valve surgical repair in people with primary mitral regurgitation who are eligible for open-heart surgery. If successful, a press release states, the trial has the potential to [...]

2020-01-15T14:51:51+00:00January 15th, 2020|Tags: , , |

FDA clearance granted to Penumbra for Indigo Aspiration System

Penumbra has announced FDA 510(k) clearance for expanded indication of its Indigo aspiration system. As part of the system, Indigo aspiration catheters and separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and now for the treatment of pulmonary embolism. Penumbra introduced [...]

2020-01-15T14:49:07+00:00January 15th, 2020|Tags: , , |

Alucent Biomedical announces FDA approval to proceed with Natural Vascular Scaffolding trial

Alucent Biomedical has received FDA approval to proceed with a phase 1 clinical trial to evaluate the safety and efficacy of its revolutionary Natural Vascular Scaffolding (NVS) technology. The therapy is designed to treat peripheral arterial disease of the lower extremities. The Alucent NVS vessel restoration system with photoactivated linking combines standard angioplasty with [...]

2020-01-15T14:45:50+00:00January 15th, 2020|Tags: , , |

FDA grants Breakthrough Device Designation Temporary Spur stent system

Reflow Medical announced that its Temporary Spur stent system—novel retrievable stent technology intended for the treatment of below-the-knee peripheral arterial disease—has been designated for the Breakthrough Devices Program by FDA. The Temporary Spur stent system is a novel combination device that consists of consisting of a retrievable stent system. The system has a series [...]

2020-01-15T14:41:48+00:00January 15th, 2020|Tags: , , |

Medtronic receives FDA clearance for Stealth Autoguide system for cranial procedures

The FDA has cleared the Stealth Autoguide system (Medtronic), which a press release reports is the first cranial robotic platform to integrate with Medtronic’s enabling technology portfolio to create an end-to-end procedural solution. The Stealth Autoguide Platform is a robotic guidance system intended for the spatial positioning and orientation of instrument holders or tool [...]

2020-01-03T11:51:16+00:00January 3rd, 2020|Tags: , , |

Life Spine announces FDA 510(k) clearance of the titanium stand-alone ALIF spacer system

Life Spine has received FDA clearance to market its titanium stand-alone anterior lumbar interbody fusion (ALIF) spacer system. The system comes in footprints of 34mm x 24mm, 38mm x 28mm and 42mm x 30mm. Additionally, there are three lordotic options of 6 degrees, 12 degrees and 18 degrees and heights ranging from 11mm to [...]

2020-01-03T11:47:29+00:00January 3rd, 2020|Tags: , , , , |

NuVasive appoints Matthew K Harbaugh as chief financial officer

Matthew K Harbaugh has been appointed as executive vice president and chief financial officer (CFO) of NuVasive. Harbaugh succeeds Rajesh (Raj) J Asarpota, who will transition from the company. A press release reports that Harbaugh brings more than 25 years of experience in finance, business and strategy, and operations management. As CFO, Mr. Harbaugh [...]

2020-01-03T11:43:57+00:00January 3rd, 2020|Tags: , , |

Jean-Claude Dubacher named chairman and CEO of B Braun Medical

Jean-Claude Dubacher B Braun has announced the appointment of Jean-Claude Dubacher as chairman and CEO. Dubacher joined B Braun on 1 August 2019 as president, B Braun Medical. A press release reports that Dubacher’s experience in the healthcare industry spans more than 15 years in consulting and corporate roles, including strategy, commercial, [...]

2020-01-03T11:36:49+00:00January 3rd, 2020|Tags: , |

Fujifilm to acquire Hitachi’s diagnostic imaging-related business

Fujifilm has entered into an agreement with Hitachi to acquire the latter’s diagnostic imaging-related business to further expand its Healthcare business. Prior to the acquisition, Hitachi will establish a company and implement an absorption-type company split whereby the new company will absorb the business. Under the share purchase agreement between Fujifilm and Hitachi, according [...]

2020-01-03T11:30:34+00:00January 3rd, 2020|Tags: , , |

FDA grants Breakthrough Designation to ECG-based low ejection fraction screening algorithm

Eko DUO digital stethoscope Eko has announced that the FDA has granted the company breakthrough status for its ECG-based algorithm that is designed to provides easily accessible screening test for heart failure. A press release reports that the algorithm analyses 15 seconds of ECG data collected from the Eko DUO digital stethoscope during [...]

2020-01-03T11:27:57+00:00January 3rd, 2020|Tags: , , |

Guerbet appoints David Hale as new CEO

David Hale Guerbet’s Board of Directors has announced that David Hale has been appointed as the company’s CEO. According to a press release, chief commercial officer and group executive committee member since February 2018, David Hale takes over the position from Yves L’Epine, who has been CEO since end of 2011. For [...]

2020-01-03T11:24:48+00:00January 3rd, 2020|Tags: , |

ControlRad announces several additions to its leadership team

Peter Pizzo ControlRad, which is focused on reducing unnecessary radiation exposure during fluoroscopically guided procedures (FGP), has announced several additions to its leadership team. Joining are Peter Pizzo as chief financial officer, Amy Lazarus as vice president of USA operations, Joe Ross as vice president of marketing, and Sean Finnerty and Tim [...]

2019-12-17T17:10:16+00:00December 17th, 2019|Tags: , |

Approvals & refusals—December 2019

Each month, BIBA Briefings compiles a list of market approvals (European or US), FDA Device Designations, and recalls. For example, in December 2019, Cryolife received CE marks for two stent grafts (E-nya and E-nside), EOS imaging received 510(k) clearance from the FDA for its new generation imaging system (EOSedge), and Aleva Neurotherapeutics was awarded [...]

2019-12-17T11:42:40+00:00December 17th, 2019|Tags: |

FDA approval for Bashir endovascular catheter—Short Basket

Thrombolex has received FDA clearance for its Bashir endovascular catheter—Short Basket (BEC S-B). The indication for use of the BEC S-B is for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. A press release reports that Thrombolex provides an innovative line of endovascular catheters, which feature a unique [...]

2019-12-17T11:29:40+00:00December 17th, 2019|Tags: , , |

CE mark for directSTIM deep brain stimulation system

DirectSTIM Aleva Neurotherapeutics has been awarded the CE mark for its—a press release reports—flagship product, the directSTIM deep brain stimulation (DBS) system. According to the press release, Aleva’s revolutionary DBS system incorporates directional electrode technology and is designed to be more precise and efficient, with optimised stimulation that will potentially reduce side [...]

2019-12-17T11:26:25+00:00December 17th, 2019|Tags: , , |

Robocath completes first robotic coronary angioplasties in Africa

R-One Robocath has announced it has successfully completed six robotic coronary angioplasties with R-One, which a press release says is a first for the continent of Africa. Faizel Lorgat (Netcare Christiaan Barnard Memorial Hospital, Cape Town, South Africa) performed the percutaneous coronary intervention (PCI) procedures as part of a distribution agreement with [...]

2019-12-16T14:40:36+00:00December 16th, 2019|Tags: , |

European Innovation Council (EIC) accelerator programme grant FEops €3.2m

The FEops team FEops has been awarded a grant of €3.2m from the European Innovation Council (EIC) accelerator programme. The grant, a press release reports, will accelerate the clinical evidence gathering and business implementation of FEops HEARTguide predictive preoperative planning for transcatheter structural heart interventions on a worldwide scale. According to the [...]

2019-12-16T14:34:27+00:00December 16th, 2019|Tags: , , , |

Imperative Care announces $85m Series C Financing for stroke treatments

Imperative Care has completed the initial closing of a Series C financing of $85m to support the commercial launch of its portfolio, which is composed of the latest advances in neurovascular devices treating ischaemic and haemorrhagic strokes. The round was co-led by new investors Ally Bridge Group and Bain Capital Life Sciences. A press [...]

2019-12-16T14:19:16+00:00December 16th, 2019|Tags: , , |

Cardiologs receives innovation award for its AI solution

Cardiologs has earned Frost & Sullivan’s New Product Innovation Award. The cloud-based artificial intelligence (AI) solution was recognised for its ability to analyse ambulatory ECG recordings faster and more reliably than traditional software, enabling clinicians to provide accurate, timely, and cost-effective arrhythmia diagnosis.  A press release reports that Cardiologs was launched in North America [...]

2019-12-17T15:04:46+00:00December 16th, 2019|Tags: , , |

Philips and Paige team up to bring AI to clinical pathology diagnostics

Philips and Paige have announced a strategic collaboration to deliver clinical-grade artificial intelligence (AI) applications to pathology laboratories. These AI technologies, starting with Paige Prostate, aim to help pathologists identify, quantify and characterise cancer in tissue samples and make precise diagnoses more efficiently. This may, ultimately, positively impact pathologist’s workflow and treatment planning for [...]

2019-12-09T13:22:50+00:00December 9th, 2019|Tags: , , , , , |

Peregrine Ventures brings total managed funds and co-invest capital to $400 Million

Eyal Lifschitz Peregrine Ventures just closed its fourth fund—Peregrine 4—raising $115 million. Their partners include some of the leading institutional and private equity investors from Israel, the USA, Europe and Australia. According to a press release, Peregrine now has more than $200 million under management and has an equal amount available for [...]

2019-12-09T13:10:06+00:00December 9th, 2019|Tags: , |

ICI 2019: Append to present its first-of-its-kind, no implant LAA closure system

LAA closure Append Medical is to present a novel left atrial appendage (LAA) closure device—designed to minimise stroke risk in patients with atrial fibrillation patients—at the ICI Innovation Award Competition, which takes place at the 2019 Innovation in Cardiovascular Interventions (ICI) (8–10 December, Tel Aviv, Israel). A press release reports that the [...]

2020-01-09T10:46:21+00:00December 9th, 2019|Tags: , , |

Two studies suggest mortality lower with Sapien than with CoreValve

Sapien 3 and CoreValve Evolut Pro According to two studies published in Circulation, the balloon-expandable Sapien (Edwards Lifesciences) transcatheter aortic valve implantation (TAVI) system is associated with lower mortality than is the self-expanding CoreValve (Medtronic) system. These findings have led to calls for randomised head-to-head trials comparing the two devices. In their [...]

2019-12-09T10:16:22+00:00December 6th, 2019|Tags: , , , |

FDA approval of IN.PACT AV is a boon for management of dysfunctional AVFs

Andrew Holden Recently, the FDA approved Medtronic’s paclitaxel-coated balloon IN.PACT AV for the management of failing arteriovenous fistulae (AVF). Approval for the device was based on data from the IN.PACT AV Access trial, which showed the device to significantly increase primary patency compared with standard percutaneous transluminal angioplasty. Andrew Holden (Department of [...]

Transcatheter mitral valve replacement likely to be a complementary therapy to transcatheter mitral valve repair

Maurizio Taramasso Maurizio Taramasso (Department of Cardiac Surgery, University Hospital of Zurich, University of Zurich, Zurich, Switzerland) and colleagues write in EuroIntervention that transcatheter mitral valve repair and transcatheter mitral valve replacement (TMVR) “will most likely be complementary rather than competitive” therapies, adding that a “repair-first” (followed by TMVR if needed) “seems [...]

2019-12-06T15:27:23+00:00December 6th, 2019|Tags: |

CE mark for world’s smallest multivital wearable sensor and software development kit

VivaLNK VivaLNK has received a Class IIa medical device CE mark for its multivital medical wearable sensor and software development kit (SDK). According to a press release, at only 7.5grams, the reusable patch is the smallest of its kind. The press release states that the patch’s reusability factor can increase the economic [...]

2019-12-06T15:22:24+00:00December 6th, 2019|Tags: , |

FDA 510(k) clearance for its i:X handheld fluorescence imaging device for wound management

i:X MolecuLight has received FDA 510(k) clearance for its i:X handheld fluorescence imaging device for use in the detection of wounds containing bacteria. This FDA 510(k) clearance is an expansion of the original de novo clearance for the MolecuLight i:X platform, which was granted 14 August 2018. A press release reports that [...]

2019-12-06T15:16:37+00:00December 6th, 2019|Tags: , |

InnovHeart appoints Brent Ratz as independent member of the board

InnovHeart—a developer of novel transcatheter mitral valve replacement (TMVR) systems—has appointed medical device entrepreneur J Brent Ratz as non-executive independent member of its Board of Directors. A press release reports that Ratz has more than 19 years of experience in the medical device industry.  He is currently co-founder and managing director of inQB8 Medical [...]

2019-12-06T15:13:06+00:00December 6th, 2019|Tags: , , |

First UK site opens for clinical trial of novel patient-specific regenerative cell therapy for chronic limb-threatening ischaemia

Image credit: Rexgenero The first UK clinical trial site for the treatment of diabetic patients with chronic limb-threatening ischaemia using a novel patient-specific regenerative therapy has opened for patient recruitment at the University Hospital of Wales in Cardiff. The site will be evaluating REX-001 (Rexgenero) in two phase III trials codenamed the [...]

2019-12-06T15:09:13+00:00December 6th, 2019|Tags: , , , |

CryoLife receives CE mark for two of its stent grafts

E-nside CryoLife has received two CE marks, with one for the E-nside thoracoabdominal aortic aneurysm stent graft and one for the E-nya thoracic stent graft system. Two press releases announcing the CE marks, respectively, report that E-nside is the company's newest proprietary endovascular stent graft for patients with thoracoabdominal aortic disease and [...]

2019-12-09T10:35:52+00:00December 6th, 2019|Tags: , , , , |

Affidea and GE Healthcare sign a $100 million technology partnership agreement

GE Healthcare and Affidea have signed a multiyear agreement to deploy imaging and digital technologies across the Affidea network. According to a press release, GE Healthcare will install 200+ new equipment in Affidea’s network of centres across Europe. The press release states that the deal includes the provision of 60 new MRIs, 50 ultrasound [...]

2019-12-06T14:54:46+00:00December 6th, 2019|Tags: , , |

Philips’ multicentre clinical trial to assess impact of “direct to angio suite” workflow on stroke

Philips stroke workflow Philips has announced a major clinical trial to assess the impact of a “direct to angio suite” workflow on stroke patient outcomes. The study will assess the role of Philips’ advanced image-guided therapy platform to diagnose, plan and treat stroke patients in the interventional suite without requiring an initial [...]

2019-12-09T10:39:33+00:00December 2nd, 2019|Tags: , |

Novartis to buy The Medicines Company for $9.7 billion

Novartis has entered into an agreement and plan of merger with The Medicines Company to acquire the US-based biopharmaceutical company for $85 per share in cash, valuing the company at approximately $9.7 billion on a fully diluted equity basis. The offer price represents a premium of approximately 41% over The Medicines Company’s 30-day (to [...]

2019-12-09T10:01:30+00:00December 2nd, 2019|Tags: , , , , |

AHA 2019: ISCHEMIA shows no benefit for revascularisation in patients with stable ischaemic heart disease

Judith S Hochman The largest trial to date to compare revascularisation with a conservative strategy in patients with stable ischaemic heart disease has found no additional benefit a median of three years after the procedure. Data from the ISCHEMIA trial were presented at a late-breaking trial session at the American Heart Association Scientific [...]

2019-12-02T12:28:28+00:00December 2nd, 2019|Tags: , |

GE Healthcare expands intelligent Health Ecosystem with launch of Edison Developer Program to ease AI adoption

GE Healthcare GE Healthcare has launched the Edison Developer Program with the aim of accelerating the adoption and impact of intelligent applications and developer services across health systems. The programme is based on Edison, GE Healthcare’s intelligence platform, and is designed to help healthcare providers gain easier access to market-ready algorithms and [...]

2019-12-02T12:24:20+00:00December 2nd, 2019|Tags: , , , |

EOS imaging receives FDA 510(k) clearance for new-generation imaging system EOSedge

EOSedge EOS imaging has received 510(k) clearance from the FDA for its new generation imaging system, EOSedge. Receipt of FDA 510(k) clearance follows the recent commercial launch of EOSedge in Europe, Canada and Australia. A press release reports that EOSedge is the first general X-ray system powered by a high-resolution photon counting [...]

2019-12-02T12:16:44+00:00December 2nd, 2019|Tags: , , |

FDA approve PMA supplement B for i-FACTOR peptide enhanced bone graft

i-FACTOR The FDA has granted Cerapedics a premarket approval (PMA) supplement for its i-FACTOR peptide enhanced bone graft in anterior cervical discectomy and fusion (ACDF) procedures in patients with degenerative cervical disc disease. Cerapedics requested approval for an updated package insert that incorporates the 24-month follow-up data from patients enrolled in the [...]

2019-12-17T11:37:05+00:00December 2nd, 2019|Tags: , , |

Canon Medical acquires Skope Magnetic Resonance Technologies

Skope Clip-on Camera Canon Medical has concluded a contract to acquire all shares of Skope Magnetic Resonance Technologies. With a unique research and development team, a press release reports, Skope is a company devoted to providing MRI users with unprecedented imaging quality and performance. The acquisition of Skope was completed according to [...]

2019-12-02T12:03:06+00:00December 2nd, 2019|Tags: , , , |

ATEC launch SafeOp Neural InformatiX system

Alphatec Holdings has announced the commercial release of the SafeOp Neural InformatiX system, which has been designed to seamlessly integrate critical neural information into ATEC procedural solutions. The system has been engineered to provide surgeons with actionable information regarding both the location and the health of nerves at risk during surgery. Specifically, the SafeOp [...]

2019-12-02T11:59:25+00:00December 2nd, 2019|Tags: , , , |

Approvals & refusals: 18 November–22 November

Each week, BIBA Briefings summarises the key market approvals of medical devices in Europe, the USA, and other markets. It also covers recalls, safety notices, and indication withdrawals. This report (Monday 18 October to Friday 22 November) features FDA approval for IN.PACT AV, a recall for a guidesheath, and FDA Breakthrough Device Designation for [...]

2019-11-25T13:38:32+00:00November 25th, 2019|Tags: |

FDA Breakthrough Device Designation for Wrapsody endovascular stent graft system

Wrapsody Merit Medical has been granted Breakthrough Device Designation by the FDA for the Wrapsody endovascular stent graft system. A press release reports that the Wrapsody system is a flexible, self-expanding endoprosthesis for which Merit intends to seek indication for use in haemodialysis patients for the treatment of stenosis within the central veins [...]

2019-11-25T13:27:35+00:00November 25th, 2019|Tags: , , , |

Ultromics receives FDA Clearance for its AI-powered decision support system EchoGo Core

EchoGo Ultromics has received 510(K) clearance from the FDA for its image analysis system, EchoGo Core. According to a press release, the clearance is a major milestone for Ultromics and enables the business to make EchoGo available to clinicians and healthcare providers in the USA. EchoGo applies artificial intelligence (AI) to automate [...]

2019-11-25T13:20:00+00:00November 25th, 2019|Tags: , , |

Terumo buys Aortica to further grow its vascular graft business

Terumo has decided to acquire Aortica corporation, which is a US-based company dedicated to advancing the science of personalised vascular therapy. Aortica has developed an automated case planning software known as “AortaFit”, which is designed to precisely match fenestrations on an endograft with the unique locations of each individual patient’s branch arteries during fenestrated [...]

2019-11-25T13:14:15+00:00November 25th, 2019|Tags: , , , , , |

FDA greenlight Medtronic’s paclitaxel-coated balloon for treating arteriovenous fistula lesions

IN.PACT AV Medtronic has announced FDA approval of its IN.PACT AV drug-coated balloon—a paclitaxel-coated balloon indicated for the treatment of failing arteriovenous access in patients with end-stage renal disease (ESRD) undergoing dialysis. According to a press release, randomised trial results from the IN.PACT AV Access trial show that IN.PACT AV drug-coated balloon [...]

2019-11-25T13:06:38+00:00November 25th, 2019|Tags: , , |

Siemens Healthineers markets new Somatom X.cite CT scanner

Somatom X.cite Siemens Healthineers presents its new Somatom X.cite single-source CT scanner, together with the new myExam Companion user guiding system, based on artificial intelligence (AI). According to a press release, the intelligent user guidance system guides the user through the workflow using specific questions. This user interface, and the latest scanner [...]

2019-11-25T13:01:43+00:00November 25th, 2019|Tags: , , , |

LivaNova bow out of transcatheter mitral valve replacement

A press release reports that LivaNova is to discontinue its Caisson transcatheter mitral valve replacement programme and will undertake a restructuring of its heart valve business to improve profitability and ensure business continuity. It adds that LivaNova’s heart valve business line represented nearly $130 million in revenue for full-year 2018 and has experienced a [...]

2019-11-25T12:55:19+00:00November 25th, 2019|Tags: , , , |

FDA give 510(k) clearance to Longbow titanium lateral expandable spacer system

Life Spine has received clearance from the FDA to market the Longbow titanium lateral expandable spacer system. A press release reports that system is available in lengths ranging from 45mm to 60mm, heights from 9mm to 15mm, 0 degrees and 7 degrees lordotic options and widths that expand from 15mm to 27mm anterior to [...]

2019-11-25T12:51:24+00:00November 25th, 2019|Tags: , , , |

FDA Breakthrough Device Designation granted to Revivent TC transcatheter ventricular enhancement system

Revivent TC The FDA has granted Breakthrough Device Designation status for its Revivent TC transcatheter ventricular enhancement system (BioVentrix) for heart failure. A press release reports that the less invasive ventricular enhancement (LIVE) procedures uses Revivent TC System to exclude scar tissue on the left ventricle that has resulted from a myocardial [...]

2019-11-20T13:02:50+00:00November 20th, 2019|Tags: , , |

Edwards Lifesciences recalls gudiesheath for its Pascal transcatheter mitral valve repair system

Edwards Lifesciences has issued a recall for the guidesheath (model number: 10000GS and 10000GSCE) that is used in conjunction with the Pascal system for the transcatheter repair of mitral valve regurgitation. According to a letter sent to physicians, there is a potential for damage to the inner liner of the guidesheath because of a [...]

2019-11-20T12:15:51+00:00November 20th, 2019|Tags: , , |

Robert B Ford to take over as CEO of Abbott next year

Miles D White will be stepping down, after 21 years, as CEO of Abbott on 31 March 2020. According to a press release, White’s tenure is the second longest for a non-founder in today’s S&P 100; he will remain executive chairman of the Board. The Board has unanimously appointed Robert B Ford—a 23-year Abbott [...]

2019-11-20T12:12:41+00:00November 20th, 2019|Tags: , |

Brainlab launch Mixed Reality Viewer to help bring spatial computing into daily clinical practice

Mixed Reality Viewer Brainlab has launched the Mixed Reality Viewer, which is designed to bring spatial computing into daily clinical practice for surgical plan review, medical student training and patient consultation. A press release reports that the Mixed Reality Viewer uses the head-mounted display Magic Leap One (from Brainlab strategic development partner [...]

2019-11-20T12:07:39+00:00November 20th, 2019|Tags: , |

Corindus completes first-ever, transcontinental simulated telerobotic PCI procedures over 5G, fibre, and public internet networks

CorPath GRX Corindus, now part of Siemens Healthineers, has completed the first multi-city, transcontinental percutaneous coronary intervention (PCI) simulations in the USA over three network connection types: 5G wireless, dedicated fibre, and commercial public internet networks. A press release reports that Ryan Madder (Frederik Meijer Heart & Vascular Institute, Spectrum Health, Grand [...]

2019-11-20T12:03:46+00:00November 20th, 2019|Tags: , , |

AHA 2019: Positive data for Cordella PA pressure sensor system

Data presented at the 2019 American Heart Association Scientific Sessions (16–18 November, Philadelphia, USA), a press release reports, confirm the accuracy and safety of the Cordella pulmonary artery (PA) pressure sensor system (Cordella Sensor, Endotronix). The PA sensor system, with the Cordella system, is designed to proactively deliver the information necessary to improve heart [...]

2019-11-20T11:59:54+00:00November 20th, 2019|Tags: , |

InVivo Therapeutics appoints Robert Rosenthal to Board of Directors

InVivo Therapeutics has appointed Robert J Rosenthal to the company’s Board of Directors, effective 8 November 2019. According to a press release, Rosenthal brings more than 25 years of experience to the InVivo Board as an accomplished executive and business leader in the biotechnology, therapeutics and medical device industries. With the addition of Rosenthal, [...]

2019-11-20T11:56:35+00:00November 20th, 2019|Tags: , |

CE mark for first-in-class prostate cancer detection solution

Paige has received the CE mark for Paige Prostate, which a press release reports is a first-in-class prostate cancer detection solution. Along with Paige Insight, an artificial intelligence (AI) native digital pathology viewer, Paige Prostate is designed for primary diagnosis. The press release states that these solutions are vendor neutral and allow for seamless [...]

2019-11-20T11:52:53+00:00November 20th, 2019|Tags: , , |

Study indicates novel “cuffless” blood pressure monitor has potential to replace traditional methods

Aktiia blood pressure monitor According to a study in the peer-reviewed journal Blood Pressure Monitoring, a wrist-based optical blood-pressure monitor could be used for ambulatory blood pressure monitoring—removing the need for a cuff-based monitoring system. According to a press release, the novel system (Aktiia) uses the same sensors that are used in [...]

2019-11-11T14:31:34+00:00November 11th, 2019|Tags: |

Google enter definitive agreement to buy Fitbit

Fitbit has entered into a definitive agreement to be acquired by Google for $7.35 per share in cash, valuing the company at a fully diluted equity value of approximately $2.1 billion. A press release reports that Fitbit pioneered the wearables category by delivering innovative, affordable and engaging devices and services. It adds that Fitbit [...]

2019-11-11T14:37:18+00:00November 11th, 2019|Tags: , , , |

Shockwave launch DISRUPT CAD IV study to support Japanese device approval

Shockwave Lithotripsy Shockwave Medical has announced that it has initiated the DISRUPT CAD IV study of is intravascular lithotripsy (IVL) system for the management of in heavily calcified coronary arteries, with the intention of using data from the study to supporting regulatory device approval in Japan. Shigeru Saito (Shonan Kamakura General Hospital, [...]

2019-11-11T15:15:29+00:00November 11th, 2019|Tags: , , |

Life Spine agrees to pay US government $5.5million over historical shortcomings in compliance programme

Life Spine has entered into a settlement agreement with the USA government that successfully resolves all of the government’s claims. As part of the agreement, it will pay $5.5 million to the US government which noted historical shortcomings in its compliance programme. A press release reports that the company has made significant progress formalising [...]

2019-11-11T14:13:12+00:00November 11th, 2019|Tags: , |

FDA approve the Senza Omnia spinal cord stimulation system for chronic pain

Senza Omnia Nevro has received approval from the FDA for the Senza Omnia spinal cord stimulation (SCS) system. A press release reports that the Omnia system is the first and only SCS system designed to deliver Nevro’s proprietary HF10 therapy in addition to all other available SCS frequencies. The Omnia system is [...]

2019-11-11T14:08:32+00:00November 11th, 2019|Tags: , , |

US Patent No 10,463,486 issued for Valfix Medical

Valfix Medical has announced the issuance of US Patent No. 10,463,486 (5 November 2019). According to a press release, this is the second US patent granted for Valfix and was approved only two years and nine months since its priority date. This new patent provides an additional layer of protection for Valfix’s transcatheter repair [...]

2019-11-11T14:01:36+00:00November 11th, 2019|Tags: , |

Approvals & refusals: 28 October–1 November

Each week, BIBA Briefings summarises the key market approvals of medical devices in Europe, the USA, and other markets. It also covers recalls, safety notices, and indication withdrawals. This report (Monday 28 October to Friday 1 November) features a CE mark approval for Vascade MVP (Cardiva Medical), FDA Breakthrough Device Designation for Surmodics' Sundance [...]

2019-11-04T16:15:56+00:00November 4th, 2019|Tags: |

XACT robotic system cleared for percutaneous interventional procedures in the USA

Harel Gadot XACT Robotics has announced that its first robotic system was cleared to market in the USA for use during computed tomography (CT) guided percutaneous interventional procedures. A press release states that XACT’s technology is the “first hands-free robotic system combining image-based planning and navigation with insertion and steering of various [...]

2019-11-04T15:49:14+00:00November 4th, 2019|Tags: , |

Sundance balloon becomes the latest sirolimus peripheral device to receive FDA Breakthrough Device Designation

Surmodics has announced that the FDA has designated its Sundance sirolimus-coated balloon (SCB) catheter as a Breakthrough Device under the agency’s Breakthrough Devices programme. The FDA has already designed the sirolimus devices MagicTouch (Concept Medical), Virtue sirolimus-eluting balloon (Orchestra BioMed), and Selution sustained limus release (MedAlliance) as Breakthrough Devices. The Sundance SCB has been [...]

2019-11-04T15:45:50+00:00November 4th, 2019|Tags: , , |

Orsiro soon to be available in China following market approval

The Chinese National Medical Products Administration has granted market approval to Biotronik’s sirolimus-eluting Orsiro stent. A press release reports that the company expects to make the device, which has a biodegradable polymer, available to Chinese patients and physicians in the coming months. As the second largest drug-eluting stent market in the world, China is [...]

2019-11-04T16:04:20+00:00November 4th, 2019|Tags: , , |

FDA Breakthrough Device Designation for “fully implantable” LVAD

Medtronic has received Breakthrough Device Designation from the FDA for a novel implantable left ventricular assist device (LVAD) for patients with advanced heart failure. A press release reports that, rather than the current LVAD systems that require a driveline cable that extends outside the body to a controller, the future system is designed to [...]

2019-11-04T15:38:29+00:00November 4th, 2019|Tags: , |

Valiant Navion TEVAR system approved for use in Japan

Valiant Navion Medtronic has received Shonin approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its Valiant Navion thoracic endovascular aortic repair (TEVAR) system. Consequently, the company has launched the system in Japan for minimally invasive repair of thoracic descending aortic aneurysms and complicated type B aortic dissections.  According [...]

2019-11-04T15:34:48+00:00November 4th, 2019|Tags: , , |

FDA approve PMA supplement for Optimizer Smart system

Optimizer Smart Impulse Dynamics, developer of the Optimizer Smart system for delivering cardiac contractility modulation (CCM) therapy, has received FDA approval of a PMA supplement for its next generation, two-lead Optimizer Smart system for the treatment of heart failure. According to a press release, the Optimizer Smart system offers a new therapy [...]

2019-11-04T15:50:32+00:00November 4th, 2019|Tags: , , |

FDA 510(k) clearance for AI One Click cardiac MRI package

One Click MRI HeartVista has received 510(k) clearance from the FDA for its artificial intelligence (AI) assisted One Click MRI acquisition software for cardiac exams. A press release reports that with HeartVista’s solution, cardiac MRI is now simple, time-efficient, affordable, and highly consistent. It adds that, prior to the HeartVista system, the [...]

2019-11-04T15:25:53+00:00November 4th, 2019|Tags: , , |

CE mark for Vascade MVP venous vascular closure system

Vascade MVP Cardiva Medical has received the CE mark for its Vascade MVP venous vascular closure system. Additionally, the AMBULATE study has been published in JACC: Clinical Electrophysiology. According to a press release, the AMBULATE study demonstrates the safety and efficacy of the system compared with manual compression. The press release adds [...]

2019-11-04T15:21:17+00:00November 4th, 2019|Tags: , , |

AliveCor and Huami announce a “multi-faceted global strategic alliance”

KardiaMobile AliveCor and Huami have come together to create a multi-faceted global strategic alliance, according to a press release, that combines the technologies of each company to deliver a new generation of medical functionality to wearable devices. The press release reports that the agreement encompasses the licensing of AliveCor technology and an [...]

2019-11-05T10:34:51+00:00November 4th, 2019|Tags: , , , |

First sirolimus device for peripheral arterial disease enters European market

MagicTouch AVF Concept Medical has received the CE mark for its MagicTouch sirolimus-coated percutaneous transluminal angioplasty (PTA) catheter, making the catheter the first commercially available sirolimus device for peripheral arterial disease. The MagicTouch catheter has also been approved for treating erectile dysfunction (MagicTouch ED) and for managing arteriovenous fistula complications (MagicTouch AVF). [...]

Siemens Healthineers completes its acquisition of robotics company Corindus

CorPath GRX As of 29 October 2019, Siemens Healthineers now owns Corindus Vascular Robotics—developer of a robot-assisted system (CorPath) for interventional coronary and vascular procedures. A press release reports that, prior to the closing of the acquisition, 87.5% of Corindus’ stakeholders approved the purchase. It adds that the company is now part [...]

2019-11-07T14:13:56+00:00October 29th, 2019|Tags: , , , |

FDA provides further information on endoleaks with Endologix’s AFX endovascular grafts

The FDA has issued a new safety communication about Type III endoleaks with AFX endovascular grafts (Endologix). According to the safety communication, there may be a higher risk of Type III endoleaks with the use of AFX with Duraply and with AFX2. The FDA reports that this communication is based on a review of [...]

2019-11-04T15:53:34+00:00October 29th, 2019|Tags: , , , , |

Approvals & refusals: 21 October–25 October

CE mark—TrelliX embolic coil system (Shape Memory Medical) Shape Memory Medical has received the CE mark for its TrelliX embolic coil system. A press release reports that the TrelliX embolic coil system is intended to obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. The CE-marked indications include: intracranial [...]

2019-10-28T17:06:23+00:00October 28th, 2019|Tags: |

CorFlow Therapeutics receive Breakthrough Device Designation for PCI diagnostic device

CorFlow Therapeutics has been granted Breakthrough Device designation from the FDA for its CorFlow Controlled Flow Infusion (CoFITM) system. According to a press release, the device is included in the Breakthrough Designation programme with the indication for use statement: “The CoFITM System is indicated for diagnostic assessment of the coronary microcirculation immediately following PCI (“stenting”), [...]

2019-11-04T15:14:31+00:00October 28th, 2019|Tags: , |

Venarum Medical receives ongoing NIH SBIR grant for its endovenous valve system

Venarum Medical is in receipt of a mentorship grant in further support of its awarded Phase II SBIR Grant “EVVS: EndoVenous Valve System” currently underway. Under its Phase II work, Venarum proposes to verify the preclinical safety of the endovenous valve system (EVVS). A press release reports that the valve system is a novel [...]

2019-10-28T16:28:14+00:00October 28th, 2019|Tags: , , |

AI stroke care company Viz.ai raises $50 million in Series B round funding

Viz.ai, who is developing the first synchronised healthcare software (Viz) using artificial intelligence (AI), has announced a $50 million Series B funding. A press release reports that the funding round was led by Greenoaks with participation from Threshold Ventures, CRV along with existing investors GV and Kleiner Perkins. The press release adds that Viz.ai [...]

2019-11-07T17:06:00+00:00October 28th, 2019|Tags: , |

Chinese FDA approve Restore drug-coated balloon for in-stent restenosis and small vessel disease

Restore (Cardionovum), a paclitaxel-coated coronary balloon, now has Chinese market approval for in-stent restenosis and small vessel disease. The approval was given based on the results from two clinical studies in Chinese populations: RESTORE ISR CHINA and RESTORE SVD CHINA. RESTORE ISR CHINA and RESTORE SVD CHINA were both multicentre, randomised controlled trials. RESTORE [...]

2019-10-28T17:00:50+00:00October 28th, 2019|Tags: , , |

Medtronic continue to show faith in rhBMP-2 despite past controversies

Infuse The US Food and Drug Administration (FDA) has approved a new prospective, randomised clinical trial evaluating the use of recombinant human bone morphogenetic protein-2 (rhBMP-2, Infuse, Medtronic) during transforaminal lumbar interbody fusion (TLIF) procedures. The study is part of Medtronic’s long-term global clinical trial programme (BONE) evaluating the safety and efficacy [...]

2019-10-24T15:03:03+00:00October 24th, 2019|Tags: , , , |

GTX medical BV and NeuroRecovery Technologies merge to create Neurostimulation company for spinal cord injury

GTX medical BV (GTX) and NeuroRecovery Technologies have announced they have merged to create a company committed to developing novel neuromodulation therapies to improve functional recovery of people with spinal cord injuries; the merged entity will be known as GTX medical BV. Furthermore, the Christopher & Dana Reeve Foundation—a non-profit organisation dedicated to advancing [...]

2019-10-24T14:46:05+00:00October 24th, 2019|Tags: , |

Perflow Medical receives CE Mark approval for novel Cascade Agile

Perflow Medical has received CE mark approval for the Cascade Agile non-occlusive remodelling net (Cascade Agile). Expanding the Cascade product family, a press release reports, the Cascade Agile optimises control for distal and tortuous vessel anatomy during coil embolisation of intracranial aneurysms. The Cascade Agile is the latest addition to Perflow’s portfolio of novel [...]

2019-10-24T14:38:55+00:00October 24th, 2019|Tags: , , |

Shape Memory Medical receives CE mark for the TrelliX embolic coil system

TrelliX Shape Memory Medical has received the CE mark for its TrelliX embolic coil system. A press release reports that the TrelliX embolic coil system is intended to obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. The CE-marked indications include: intracranial aneurysms, other neurovascular abnormalities such [...]

2019-10-28T16:59:14+00:00October 24th, 2019|Tags: , , |

MagicTouch becomes first sirolimus-coated balloon for peripheral arteries to receive the CE mark

MagicTouch AVF Concept Medical BV has received the CE mark for its range of MagicTouch drug-coated balloons. The balloons are indicated for peripheral arterial disease, erectile dysfunction, arteriovenous fistula and arteriovenous graft. The CE mark approvals mean that the MagicTouch percutaneous transluminal angioplasty (PTA) catheter is the only commercially available, CE-mark certified, [...]

2019-10-24T14:15:39+00:00October 24th, 2019|Tags: , , |

FDA grant clearance for AiCE for use with ultra-high resolution CT

Canon Medical has received 510(k) clearance on its advanced intelligent Clear-IQ engine (AiCE) for the Aquilion Precision, which further expands access to its new deep convolutional neural network (DCNN) image reconstruction technology. This technology, now available on both the Aquilion Precision and Aquilion ONE/GENESIS Edition premium computed tomography (CT) systems, uses a deep learning [...]

Michael C Greiner to step down as CFO of AngioDynamics

A press release reports that the Michael C Greiner, executive vice president and chief financial officer (CFO), of AngioDynamics will be departing the company. It adds that Stephen A Trowbridge—senior vice president and general counsel—will assume the role of interim Chief Financial Officer in addition to his current responsibilities. Greiner will remain with AngioDynamics [...]

2019-10-24T14:03:54+00:00October 24th, 2019|Tags: , |

Approvals & refusals: 14 October–18 October

FDA 510 (k) clearance—FluoroShield (Omega Medical) Omega Medical Imaging, manufactures of Artificial Intelligence Fluoroscopy/Cine (AIF/C) Imaging systems, has received FDA 510 (k) clearance for its FluoroShield with their 2020 Cardiac Flat Panel Detector. A press release reports that the FluoroShield system allows for auto collimation during interventional fluoro or cine cases while maintaining a [...]

2019-10-21T14:43:29+00:00October 21st, 2019|Tags: |

Bentley named as FOCUS Growth Champion 2020

The medical technology Bentley company has been named FOCUS Growth Champion 2020. A press release reports that—together with Statista, one of the world’s biggest online statistics platforms—the magazine FOCUS searched for the top 500 companies to have achieved a high percentage of sales growth between 2015 and 2018. Only companies with their headquarters in [...]

2019-10-21T14:37:21+00:00October 21st, 2019|Tags: |

Michael J McNulty is appointed as vice president of sales and marketing of Miach Orthopaedics

Mike McNulty Miach Orthopaedics has announced that Michael J McNulty has joined the company as vice president of sales and marketing. According to a press release, McNulty will lead Miach’s commercialisation and sales efforts for the Bridge-Enhanced ACL Repair (BEAR) Implant—an investigational device designed for anterior cruciate ligament repair. McNulty brings more [...]

2019-10-21T14:30:05+00:00October 21st, 2019|Tags: , |

Omega Medical Imaging become first-in-the world to receive FDA clearance on AI imaging system that reduces radiation

Omega Medical Imaging, manufactures of Artificial Intelligence Fluoroscopy/Cine (AIF/C) Imaging systems, has received FDA 510 (k) clearance for its FluoroShield with their 2020 Cardiac Flat Panel Detector. A press release reports that the FluoroShield system allows for auto collimation during interventional fluoro or cine cases while maintaining a perspective of surrounding anatomy. The blended [...]

2019-10-21T14:31:51+00:00October 21st, 2019|Tags: , , |

FDA approval for two low-dose paclitaxel-coated balloons for peripheral arterial disease

Stellarex 0.035 Philips has added two new balloons to its portfolio of Stellarex 0.035 low-dose drug-coated balloons, following approval from the FDA. The new 200mm and 150mm Stellarex 0.035 low-dose balloons are now approved and available, in the USA, for the treatment of de novo and restenotic lesions in native superficial femoral [...]

2019-10-21T14:17:07+00:00October 21st, 2019|Tags: , , |

Novel and Emerging Technologies (NET) grant for new technology to detect heart failure

Sern Lim Heart Research UK has awarded the Novel and Emerging Technologies (NET) grant—of almost £150,000—to Sern Lim (Queen Elizabeth Hospital, Birmingham, UK) and colleagues for a project that is evaluating the use of wave intensity analysis (WIA) to diagnose heart failure and assess patients who may benefit from left ventricular assist [...]

2019-10-21T14:12:05+00:00October 21st, 2019|Tags: , |

Lack of financing prompt Titan Medical to withdraw forecasts relating to its robotic system

Titan Medical is withdrawing all forecasts with respect to the cost and timing of the development of its robotic surgical system beyond the fourth quarter of 2019 because its lack of financing has caused its primary product development supplier to limit the development work on its robotic surgical system. This supplier has also terminated [...]

2019-10-21T14:05:58+00:00October 21st, 2019|Tags: , , |

UC San Francisco’s Health Hub reveals winners of its Digital Health Awards

AliveCor receiving their award UC San Francisco’s Health Hub—an innovation hub and startup studio supporting the next wave of digital health entrepreneurs—has announced the winners of its Digital Health Awards. A press release reports that this awards event celebrates the achievements of innovative companies dramatically improving healthcare with technology. The winners were [...]

2019-10-21T14:01:53+00:00October 21st, 2019|Tags: , |

Vygon acquires firm that specialises in ECG guidance devices

Pilot TLS Vygon has acquired the Italian firm Pilot, which specialises in ECG guidance devices. The aim of this transaction, according to a press release, is to acquire the ECG location and navigation technology of the Pilot TLS product (already marketed by Vygon). The press release states that Pilot TLS is one [...]

2019-10-21T13:57:12+00:00October 21st, 2019|Tags: , |

Michael Jaff joins Boston Scientific to drive innovation in peripheral technologies

Michael Jaff Michael R Jaff is to be vice president, clinical affairs, innovation and technology, peripheral interventions of Boston Scientific by January 2020. In this role, a press release reports, Jaff will lead clinical and medical affairs strategies to support the development and commercialisation of the company’s peripheral vascular medical device portfolio, [...]

2019-10-21T13:48:15+00:00October 16th, 2019|Tags: , |

Admedus sells distribution rights of CardioCel and Vascucel to focus on TAVI programme

CardioCel Admedus has sold its CardioCel and VascuCel patch business to US-based LeMaitre Vascular for up to $A36.2M ($A22.8M upfront) in cash payments. A press release reports that these products originated from the Admedus’s proprietary, regenerative bioscaffold platform technology and are used to address multiple cardiovascular procedures and repairs. The company’s CEO, [...]

2019-10-15T13:50:18+00:00October 15th, 2019|Tags: , , |

CE mark renewed for BioCardia’s Helix biotherapeutic delivery catheter and Morph guide catheter through May 2024

Helix BioCardia has announced the renewal of the CE mark for its Helix biotherapeutic delivery catheter and Morph universal deflectable guide catheter—both are used in the delivery of biotherapeutics to the heart. A press release reports that the CE mark renewal enables BioCardia to continue supporting partners conducting biotherapeutic clinical trials outside [...]

2019-10-15T13:46:43+00:00October 15th, 2019|Tags: , , , |

FDA Breakthrough Device Designation for IASD for heart failure

IASD Corvia Medical has received FDA Breakthrough Device Designation for its Interatrial Shunt Device (IASD) for heart failure. A press release reports that the IASD is the world’s first transcatheter device for heart failure with preserved (HFpEF) and mid-range (HFmrEF) ejection fraction. It is designed to provide continuous and dynamic decompression of [...]

2019-10-15T13:42:45+00:00October 15th, 2019|Tags: , , |

FDA approves device for stimulation of the calf muscles to prevent venous thrombosis

The FDA has approved a device (geko, Sky Medical Technology) for stimulation of the calf muscles to prevent venous thrombosis in non-surgical patients at risk for venous thromboembolism. A press release reports that this adds to Sky’s established 510k clearance for immediate post-surgical stimulation of calf muscles to prevent venous thromboembolism, increasing blood circulation [...]

2019-10-15T13:37:22+00:00October 15th, 2019|Tags: , , |

Guerbet signs an agreement with icometrix for the exclusive distribution of AI imaging solution icobrain

Guerbet has signed an exclusive agreement with icometrix for the distribution in France, Italy and Brazil of icobrain, their Saas (software as a service) artificial intelligence (AI) based medical imaging solution. According to a press release, icobrain is designed to help radiologists and neurologists diagnose and monitor patients with neurological disorders. The AI software [...]

2019-10-15T13:33:17+00:00October 15th, 2019|Tags: , , , , |

First patient enrolled in study of CAT RX aspiration catheter for thrombus removal in coronary vessels

CAT RX Penumbra has announced the enrolment of the first patient in its CHEETAH study, a prospective, multicentre US study to evaluate the safety and performance of the Indigo system with CAT RX aspiration catheter in the coronary vessels. Introduced in 2018, as part of the Indigo aspiration system, the Indigo CAT [...]

2019-10-15T13:26:19+00:00October 15th, 2019|Tags: , |

FDA give unconditional IDE approval for Torus SFA stent graft study

Torus stent graft PQ Bypass has received full approval of its investigational device exemption (IDE) trial (TORUS 2) of its Torus stent graft, which is a novel stent graft platform designed for the treatment of peripheral arterial disease in the superficial femoral artery. By acquiring early FDA feedback through the presubmission process, [...]

2019-10-15T13:23:44+00:00October 15th, 2019|Tags: , , |

FDA identifies recall of Medtronic guide catheters as Class I

Medtronic is recalling its 6Fr Sherpa NX Active Guide Catheter because of a risk of the outer material separating from the device resulting in detached fragments, which could result in the underlying stainless-steel braid wires being exposed. The FDA, in a statement, has deemed this to be a “Class I recall”. According to the [...]

2019-10-10T08:54:57+00:00October 10th, 2019|Tags: , , |

Endotronix closes expanded Series D financing round of $70 Million

Cordella system Endotronix has announced the expansion of its Series D financing round, bringing the total for the round to $70 million. The expansion syndicate for the LSP-led round includes new investment from an additional unnamed medical device strategic investor as well as participation from existing investors, including Aperture Venture Partners, BioVentures [...]

2019-10-09T15:31:42+00:00October 9th, 2019|Tags: , , |

ControlRad secures $15 Million Series B financing

ControlRad has completed $15 million in financing and has added Ryan Drant and Tim Patrick have to its board of directors. The Series B round, which was led by Questa Capital, will be used for fuelling the commercial launch of the innovative ControlRad Trace system.  A press release reports that ControlRad Trace is the [...]

2019-10-09T15:25:55+00:00October 9th, 2019|Tags: , |

CE mark for Cardioform ASD Occluder

Cardioform ASD Occluder The Gore Cardioform ASD Occluder has received the CE mark. A press release reports that the device offers physicians a clinically proven design in a device that, in a recent study, met its primary endpoint for the percutaneous, transcatheter closure of ostium secundum atrial defects (ASDs). It adds that [...]

2019-10-09T15:22:47+00:00October 9th, 2019|Tags: , , |

Avance bi-directional steerable introducer sheath now available in USA

Avance BioCardia has announced the US commercial availability of its Avance bi-directional steerable introducer sheath for introducing various cardiovascular catheters into the heart, including via the left side of the heart through the interatrial septum. The product became available in late September. A press release reports that the Avance device addresses the [...]

2019-10-09T15:03:18+00:00October 9th, 2019|Tags: , |

Medtronic launch worldwide trial to evaluate novel extravascular ICD

EV ICD Medtronic has commenced a worldwide pivotal study to evaluate an investigational extravascular implantable cardioverter defibrillator (EV ICD) system for the management of tachycardia.  A press release reports that the system is designed to provided defibrillation, as with a traditional ICD, but has a lead outside of the heart and veins. [...]

2019-10-09T15:35:01+00:00October 8th, 2019|Tags: , |

Medtronic makes FDA Submission for InterStim Micro Neurostimulator and SureScan MRI Leads

Intersim Medtronic has filed a pre-market approval (PMA) supplement with the FDA for approval of its InterStim Micro neurostimulator and also its InterStim SureScan MRI leads. InterStim Micro is a rechargeable, implantable sacral neuromodulation device designed to treat patients affected by overactive bladder, urinary urge incontinence, unobstructed urinary retention and faecal incontinence. The [...]

2019-10-10T08:50:53+00:00October 7th, 2019|Tags: , , , |

TCT 2019: TRILUMINATE feasibility study meets both the primary safety and performance endpoints

TriClip New data indicate that a novel transcatheter system for tricuspid valve repair (TriClip, Abbott) was safe and associated with strong clinical improvement at six-months—including a reduction in tricuspid regurgitation and improvement in quality of life—in patients with severe tricuspid regurgitation. The findings were presented at the 2019 Transcatheter Cardiovascular Therapeutics (TCT) [...]

2019-10-01T13:20:16+00:00October 1st, 2019|Tags: , , |

Approvals & refusals: 23 September–27 September

FDA approval—Proclaim XR (Abbott) Abbott has received FDA approval for its Proclaim XR recharge-free neurostimulation system for people with chronic pain. A press release reports that the Proclaim XR platform offers a low dose of Abbott’s proprietary BurstDR stimulation waveform, which has been designed to mimic natural patterns found in the brain. A press [...]

2019-10-01T11:19:18+00:00October 1st, 2019|Tags: |

First systematic review of AI shows it may be as effective as healthcare professionals

According to a study published in The Lancet Digital Health, artificial intelligence (AI) may be as effective as health professionals at diagnosing disease. The study represents the first systematic review and meta-analysis of the role of AI for diagnosing medical conditions.  A press release reports that the small number of high quality studies of [...]

2019-10-01T11:14:00+00:00October 1st, 2019|Tags: |

FDA PMA approval for Impella 5.5 with SmartAssist

Abiomed’s Impella 5.5 with SmartAssist has received US FDA pre-market approval (PMA) for safety and efficacy in the therapy of cardiogenic shock for up to 14 days. The Impella 5.5 with SmartAssist system is a temporary ventricular support device intended for short term (14 days) use and indicated for the treatment of ongoing cardiogenic [...]

2019-10-01T11:08:37+00:00October 1st, 2019|Tags: , , , |

FDA approves low-dose spinal cord stimulator for chronic pain

Proclaim XTR Abbott has received FDA approval for its Proclaim XR recharge-free neurostimulation system for people with chronic pain. A press release reports that the Proclaim XR platform offers a low dose of Abbott’s proprietary BurstDR stimulation waveform, which has been designed to mimic natural patterns found in the brain. The press [...]

2019-10-07T14:55:46+00:00October 1st, 2019|Tags: , , |

FDA clears modules of AI-Rad Companion Chest CT from Siemens Healthineers

The FDA has cleared three modules of AI-Rad Companion Chest CT, a software assistant from Siemens Healthineers that is designed to bring artificial intelligence (AI) to computed tomography (CT). Representing the first intelligent assistant of the new AI-Rad Companion platform, AI-Rad Companion Chest CT helps radiologists interpret images of the thorax quickly with desired [...]

2019-10-01T10:49:39+00:00October 1st, 2019|Tags: , , , |

Medtronic receive FDA nod for feasibility trial of its Intrepid transcatheter mitral valve

Intrepid Medtronic has received FDA approval to begin an early feasibility study for its Intrepid transcatheter mitral valve implantation (TMVI) system using a minimally-invasive transfemoral access approach. A press release reports that this announcement builds upon primary endpoint outcomes of the Intrepid TMVI clinical trial (APOLLO), which showed that TMVI (via the [...]

2019-10-01T10:44:58+00:00October 1st, 2019|Tags: , , , |

Developer of device for triaging stroke patients named as 2019 Global Competition Winner

MedTech Innovator has announced Forest Devices as the winner of its 2019 Global Competition. The winning company was determined by a live audience vote on 24 September at The MedTech Conference (23–25 September, Boston, USA), which is supported by AdvaMed. Forest Devices is developing a portable device that uses EEG monitoring and machine learning [...]

2019-10-01T10:40:37+00:00October 1st, 2019|Tags: |

Misonix completes acquisition of Solsys Medical

Misonix has completed its previously announced acquisition of privately held Solsys Medical in an all-stock transaction valued at approximately $109 million on the date prior to closing. A press release reports that Solsys and its leading cellular and tissue-based wound treatment, TheraSkin, is highly complementary to Misonix’s cutting-edge ultrasonic wound debridement solution, SonicOne—providing Misonix with a large direct advanced wound [...]

2019-10-01T10:35:25+00:00October 1st, 2019|Tags: , |

ASTRO 2019: Non-invasive radiation therapy has potential benefit for arrhythmia patients

According to a study presented at 2019 American Society for Radiation Oncology (ASTRO) annual meeting (15–18 September, Chicago, USA), treating high-risk heart patients with a single, high dose of radiation therapy could substantially reduce episodes of rapid, abnormal heartbeats for more than two years. In collaboration with Phillip Cuculich (Washington University School of Medicine, [...]

2019-10-01T11:00:53+00:00October 1st, 2019|Tags: |

TCT 2019: Low rate of MACE at 12 months with “world’s thinnest stent”

K Sivaprasad (Govt TD Medical College, Alappuzha, India) reported at the 2019 Transcatheter Cardiovascular Therapeutics (TCT) meeting (25–29 September, San Francisco, USA) yesterday that the Evermine 50 stent (Meril Life), which has a strut thickness of 50μm, is associated with a low rate of major adverse events (MACE) at 12 months. Previous studies have [...]

2019-09-28T17:25:44+00:00September 28th, 2019|Tags: , , , , |

TCT 2019: System for managing deep vein reflux wins Shark Tank award

Source: CRF This morning at the 2019 Transcatheter Cardiovascular Therapeutics (TCT) meeting (25–29 September, San Francisco, USA), InterVene won the TCT-Shark Tank Innovation Competition for its novel endovenous system (BlueLeaf) for forming valves in patients with deep vein reflux and/or chronic venous insufficiency. The award, which is supported by the Jon DeHaan [...]

2019-10-07T10:37:26+00:00September 27th, 2019|Tags: , , , |

TCT 2019: Interim analysis indicates favourable safety profile for AccuCinch

AccuCinch Today at the 2019 Transcatheter Cardiovascular Therapeutics (TCT) meeting (25–29 September, San Francisco, USA), data from an interim analysis of heart failure patients treated in the CorCinch FMR study were presented. These data show, a press release reports, that the AccuCinch ventricular repair system (Ancora Heart) is associated with a favourable safety [...]

2019-09-26T02:50:32+00:00September 26th, 2019|Tags: , , |

Terumo BCT offers $100,000 research grant to support patient access to care

A press release reports that Terumo BCT’s new $100,000 Therapeutic Plasma Exchange (TPE) Innovation Award will help clinical investigators expand the field of data for certain types of autoimmune conditions, known as IgG4-mediated diseases. It adds that TPE is as an established therapy for many diseases, but the understanding of how it works is [...]

2019-09-26T02:44:32+00:00September 26th, 2019|

MedAlliance receives FDA Breakthrough Device Designation for its sirolimus-eluting balloon for below-the-knee lesions

MedAlliance has been awarded FDA Breakthrough Device Designation for the Selution SLR, which is a sustained limus release drug-eluting balloon catheter for the treatment of below-the-knee disease. According to a press release, the company was the first drug-eluting balloon company in the world to receive FDA Breakthrough Device Designation status for the treatment of [...]

2019-10-01T14:53:22+00:00September 26th, 2019|Tags: , , , |

Eko secures $20 million in Series B funding

Eko has secured $20 million in Series B funding. Led by ARTIS Ventures, according to a press release, the funding will drive further research and development and commercialisation of Eko’s machine learning platform for cardiac screening and analysis. Additional new and returning investors in the round include DigiTx Partners, NTT Venture Capital (NTTVC), 3M [...]

2019-09-26T15:26:56+00:00September 26th, 2019|Tags: , , |

The FDA approve coronary ViperWire Advance with Flex Tip

Cardiovascular Systems (CSI) has announced FDA PMA approval of its ViperWire Advance coronary guidewire with Flex Tip (ViperWire Advance with Flex Tip). A press release reports that the ViperWire Advance with Flex Tip is the latest advancement to CSI’s coronary Diamondback 360 orbital atherectomy system. It adds that the new guidewire offers a combination [...]

2019-09-26T02:23:04+00:00September 26th, 2019|Tags: , , , |

First-in-human angioplasty procedures performed with R-One robotic PCI system

R-One Robocath has announced the success of its first two coronary angioplasties performed with assistance from its R-One robotic platform. The procedures were performed in France at Rouen University Hospital by Eric Durand and Rémi Sabatier, and at Clinique Pasteur in Toulouse by Jean Fajadet. According to a press release, R-One assists [...]

2019-09-26T02:17:31+00:00September 26th, 2019|Tags: , |

TCT 2019: Henry V can inspire us to develop innovative techniques for reducing radiation exposure

During a session on radiation protection technologies at the 2019 Transcatheter Cardiovascular Therapeutics (TCT) meeting (25­–29 September, San Francisco, USA), Lloyd W Klein (Rush Medical College, Chicago, USA) said that Henry V led the heavily outnumbered English army to victory at the Battle of Agincourt (1415) because he “figured out how to use an [...]

2019-10-15T12:11:36+00:00September 25th, 2019|Tags: , , |

Laurent Granier to become vice president, Cardiovascular at MedAlliance

Jeffrey B Jump, chairman and CEO of MedAlliance, has announced on LinkedIn that Laurent Granier has been appointed as VP Cardiovascular, responsible for the Cardiovascular commercial activities of MedAlliance. In his post on LinkedIn, Jump states that Granier has more than 25 years of experience in the Medical Device industry and more specifically in Cardiovascular, [...]

2019-09-23T16:35:17+00:00September 23rd, 2019|

FDA approval for Evolut PRO+

Evolut PRO+ The FDA has approved the Evolut PRO+ transcatheter aortic valve implantation (TAVI) system, which a press release states builds off the proven self-expanding, supra-annular Evolut TAVI platform. The press release adds that the Evolut PRO+ includes four valve sizes with an external pericardial tissue wrap that provides advanced sealing for [...]

2019-09-23T16:03:43+00:00September 23rd, 2019|Tags: , , , |

Finalists announced for the 2019 MedTech Innovator 2019 award

MedTech Innovator, a non-profit start-up accelerator in the medical technology industry, has announced the five companies—Flosonics Medical, Forest Devices, Koya, OncoRes Medical, and Venari Medical—that have been selected as finalists to compete for the title of “MedTech Innovator 2019”. A press release reports that these finalists were chosen from more than 800 applicants, and [...]

2019-09-23T15:53:35+00:00September 23rd, 2019|

Approvals & refusals: 16 September–20 September

CE mark— Masters HP 15mm and Amplatzer Piccolo Occluder (both Abbott) Two of Abbott’s paediatric devices—Masters HP 15mm rotatable mechanical heart valve and the Amplatzer Piccolo Occluder—have received European approval (CE mark). A press release reports that the devices, available in the USA, offer young paediatric patients and their families “hope when no other [...]

2019-09-20T16:16:03+00:00September 20th, 2019|Tags: |

Wallaby Medical announces CE mark and FDA clearance of the Avenir coil system

Wallaby Medical has announced CE mark approval and FDA 510(k) clearance of its differentiated embolic coil system—the Avenir coil system. The intended use for the Avenir coil system is for endovascular embolisation of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Avenir coil system is also intended for [...]

2019-09-20T16:09:46+00:00September 20th, 2019|Tags: , , |

Viz.ai named as one of Forbes’ most promising AI companies in the USA

Viz.ai has been recognised in the inaugural Forbes AI list as one of the USA’s 50 most promising artificial intelligence (AI) companies. The company uses AI to synchronize stroke care, with the aim of reducing time to treatment and expanding patient access to life-saving care. The Forbes AI list highlights the most promising private [...]

2019-09-20T15:59:44+00:00September 20th, 2019|Tags: , , |

TCT 2019: Companies reveal details of presentations

SS02 Several companies, including Boston Scientific and Corindus Vascular Robotics, have released details of their presentations at the upcoming 2019 Transcatheter Cardiovascular Therapeutics (TCT) meeting (25–29 September, San Francisco, USA). Ancora Heart 25 September (Wednesday); 4.35pm; Room 203 Abstract: Hypertension and heart failure therapies (session II) heart failure therapies, TCT 88—six-month outcomes [...]

2019-09-20T15:44:12+00:00September 20th, 2019|Tags: , |

RHYTHM AI successfully closes seed financing round

STAR Mapping RHYTHM AI has announced the closure of a £2.15 million seed financing round. The round was led by an affiliate of Rinkelberg Capital, a private wealth management firm based in London, and was supported by investment from founders. The proceeds will fund a multicentre study of STAR Mapping to improve [...]

2019-09-20T13:46:57+00:00September 20th, 2019|Tags: , , |

FDA approve US study of LimFlow percutaneous deep vein arterialisation (pDVA) system

pDVA LimFlow has received FDA approval for its investigational device exemption (IDE) for the PROMISE II pivotal study of the LimFlow percutaneous deep vein arterialisation (pDVA) system. PROMISE II is a multicentre, prospective, single-arm study to be conducted in the USA and Japan. Using an adaptive statistical design, the study plans to [...]

2019-09-20T13:43:15+00:00September 20th, 2019|Tags: , , |

Foldax completes first-in-human use of next-generation “Tria polymer” heart valve for aortic valve disease

Tria heart valve Foldax announced its first-in-human use of the Tria heart valve under its FDA early feasibility study for the treatment of aortic valve disease. Clinicians at Beaumont Hospital, Royal Oak, in Michigan, implanted this innovative flexible polymer heart valve, which has been designed to address durability and thrombogenicity issues of [...]

2019-09-20T15:50:57+00:00September 20th, 2019|Tags: , |

FDA issues draft “safer technologies programme for medical devices” guidance

Jeff Shuren The FDA has issued draft guidance titled “safer technologies programme for medical devices”, which is a voluntary programme that—a press release reports—is expected to significantly improve the safety of available treatments or diagnostic devices for diseases or conditions that are less serious than those eligible for the agency’s Breakthrough Devices [...]

2019-09-20T13:31:46+00:00September 20th, 2019|Tags: |

FDA grants Breakthrough Device Designation for the WiSE CRT

EBR Systems has announced that the FDA has granted Breakthrough Device Designation for its WiSE cardiac resynchronisation therapy (CRT) for the treatment of heart failure. The WiSE (wireless stimulation endocardially) CRT system is designed to improve the heart’s pumping ability by synchronising the left and right ventricles to distribute blood to the lungs and [...]

2019-09-20T13:24:52+00:00September 20th, 2019|Tags: , , |

CroíValve secures additional €4M funding to evaluate tricuspid therapies

CroíValve has secured €4 million in additional financing, which includes €2.5 million from the European Union (EU) under their Horizon 2020 SME Instrument grant and €1.5 million from Broadview Ventures and current investors (HBAN MedTech and Irrus Syndicates, Atlantic Bridge University Fund and SOSV Ventures). The funding will accelerate the development of the company’s [...]

2019-09-20T13:49:16+00:00September 20th, 2019|Tags: , |

Biotronik becomes first manufacturer to receive MDR certification for a Class III medical device

Biotronik has become the world’s first manufacturer to receive European Medical Device Regulation (MDR) certification for a Class III (highest risk) medical device. Following a successful conformity assessment, the company also obtained MDR certification for its quality management system. Class III medical devices represent the highest risk class of medical devices according to the [...]

2019-09-20T13:15:33+00:00September 20th, 2019|Tags: , , |

Active Implants receives FDA Breakthrough Device Designation for NUsurface Meniscus implant

Active Implants has announced that the NUsurface Meniscus implant has been granted a Breakthrough Device Designation from the FDA. A press release reports that the NUsurface Meniscus implant is the first “artificial meniscus” to be marketed in Europe and, if cleared by the FDA, would be the first artificial meniscus in the USA. The [...]

2019-09-20T13:16:00+00:00September 20th, 2019|Tags: , , , |

CE marks for Masters HP 15mm and Amplatzer Piccolo Occluder

Piccolo Occluder Two of Abbott’s paediatric devices—Masters HP 15mm rotatable mechanical heart valve and the Amplatzer Piccolo Occluder—have received European approval (CE mark). A press release reports that the devices, available in the USA, offer young paediatric patients and their families “hope when no other suitable treatment option may exist”.  The press [...]

2019-09-20T11:52:42+00:00September 20th, 2019|Tags: , , , |

FDA grants Fast-Track designation to develop heart failure drug

Dapagliflozin (Farixga) The FDA has granted Fast Track designation for the development of dapagliflozin (Farixga, AstraZeneca) to reduce the risk of cardiovascular death or the worsening of heart failure in adults with heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF). The FDA’s Fast Track programme is designed to [...]

2019-09-17T16:25:29+00:00September 17th, 2019|Tags: , , |

Merit Medical launches Torpedo gelatin foam for embolisation of hypervascular tumours

Torpedo Merit Medical has launched Torpedo—a proprietary gelatin foam indicated for use in the embolisation of hypervascular tumours—onto the market. According to a press release, the Torpedo provides physicians with a pre-shaped gelatin foam loaded into a cartridge with an optional blunt stylet, removing the need for manual foam shaping and providing [...]

2019-09-17T16:19:06+00:00September 17th, 2019|Tags: , |

IN.PACT arteriovenous drug-coated balloon shows promise

The IN.PACT AV access clinical study, which is evaluating the investigational IN.PACT AV drug-coated balloon for the management of patients with de novo or non-stented restenotic arteriovenous (AV) fistulae lesions, has met its primary safety and effectiveness endpoints. Data from the trial were presented today at the Cardiovascular and Interventional Radiology Society of Europe [...]

2019-09-17T16:11:11+00:00September 17th, 2019|Tags: , , |

Stereotaxis appoints Kimberly Peery as chief financial officer

Stereotaxis has appointed Kimberly Peery as chief financial officer, effective 1 October 2019. Martin Stammer, who has served as chief financial officer (CFO) since 2013, has accepted a position as the CFO of a large professional services firm headquartered in the St Louis area (USA) and will resign from the Stereotaxis, effective 30 September [...]

2019-09-17T16:06:11+00:00September 17th, 2019|Tags: , |

FDA Breakthrough Device Designation for Virtue sirolimus-eluting balloon

Virtue AVF Orchestra BioMed, in partnership with Terumo, has secured Breakthrough Device Designation by the FDA for its Virtue sirolimus-eluting balloon (SEB) in the treatment of below-the-knee peripheral arterial disease. A press release reports that currently approved therapeutic options for peripheral arterial disease are limited and have been shown to be marginally [...]

2019-09-17T15:58:59+00:00September 17th, 2019|Tags: , |

Approvals & refusals: 9 September–13 September

FDA approval—r-SNM system (Axonics) Axonics Modulation Technologies has announced the FDA approval of the Axonics r-SNM system. A press release reports that the Axonics system is the first rechargeable SNM system approved for sale in the USA, Europe, Canada and Australia. It is now approved, in the USA, for the management of faecal incontinence. [...]

2019-09-20T13:28:03+00:00September 17th, 2019|Tags: |

FDA clearance for smartphone-based test to diagnose chronic kidney disease

ACR (Healthy.io) Healthy.io has received 510(k) clearance from the FDA for its smartphone-based ACR test to be used in the aid of diagnosing chronic kidney disease. A press release reports that this is the second FDA clearance the company has received. Additionally, the company also closed a $60 million Series C funding [...]

2019-09-17T16:21:25+00:00September 17th, 2019|Tags: , , |

CroíValve secures additional €4M funding to evaluate tricuspid therapies

CroíValve has secured €4 million in additional financing, which includes €2.5 million from the European Union (EU) under their Horizon 2020 SME Instrument grant and €1.5 million from Broadview Ventures and current investors (HBAN MedTech and Irrus Syndicates, Atlantic Bridge University Fund and SOSV Ventures). The funding will accelerate the development of the company’s [...]

2019-09-17T14:55:26+00:00September 17th, 2019|Tags: , |

ARTIS icono receives FDA approval

ARTIS Icono biplane The FDA has cleared the ARTIS icono (Siemens Healtineers)—a high-precision family of angiography systems that are designed to permit a wide range of minimally invasive procedures to be performed in a single interventional suite. The ARTIS icono biplane system is engineered for optimal use in neuroradiology and abdominal imaging, [...]

2019-09-17T14:40:38+00:00September 17th, 2019|Tags: , , |

Second FDA Breakthrough Device Designation for V-Wave

V-Wave has announced that the FDA has granted it a second Breakthrough Device Designation—the first was for its interatrial shunt for heart failure and the second is for pulmonary arterial hypertension. The company is testing a minimally invasive, implanted interatrial shunt device for pulmonary artery hypertension in a global approved investigational device exemption (IDE) [...]

2019-09-17T15:30:21+00:00September 16th, 2019|Tags: , |

FDA Breakthrough Designation for Checkpoint BEST system

Checkpoint BEST Checkpoint Surgical has received FDA Breakthrough Device Designation for the Checkpoint brief electrostimulation therapy (BEST) system. The Checkpoint BEST system is, a press release reports, designed to provide electrical stimulation of peripheral nerves to promote nerve regeneration as an adjunct to surgical intervention following nerve injury, with the goal of [...]

2019-09-17T15:22:38+00:00September 16th, 2019|Tags: , , |

FDA 510(k) clearance for GE Healthcare’s Critical Care Suite

Critical Care Suite GE Healthcare has received FDA 510(k) clearance of its Critical Care Suite, which a press release reports are an industry-first collection of artificial intelligence (AI) algorithms embedded on a mobile X-ray device. Built in collaboration with UC San Francisco (UCSF), using GE Healthcare’s Edison platform, the AI algorithms are [...]

2019-09-17T15:06:34+00:00September 16th, 2019|Tags: , , , |

FDA approve Axonics’ sacral neuromodulation system

r-SNM Axonics Modulation Technologies has announced the FDA approval of the Axonics r-SNM system. A press release reports that the Axonics system is the first rechargeable SNM system approved for sale in the USA, Europe, Canada and Australia. It is now approved, in the USA, for the management of faecal incontinence. The [...]

2019-09-17T14:59:39+00:00September 16th, 2019|Tags: , , |

Abbott start trial to evaluate “TriClip” for percutaneous repair of tricuspid regurgitation

Abbott has announced its TRILUMINATE Pivotal trial to evaluate the safety and effectiveness of the TriClip transcatheter tricuspid valve repair system for the treatment of severe tricuspid regurgitation. This is the first pivotal Investigational Device Exemption (IDE) trial in the USA to evaluate a catheter-based, non-surgical treatment for patients with severe tricuspid regurgitation. The [...]

2019-09-06T18:09:53+00:00September 6th, 2019|Tags: , |

The FDA finalises its draft guidance on the Humanitarian Device Exemption programme

Jeffrey Shuren The FDA issued a final guidance, Humanitarian Device Exemption (HDE) programme, with the aim of providing provide updated information about the HDE application process and other considerations specific to the programme. An HDE application is the premarket submission for a Humanitarian Use Device (HUD), which is a medical device intended [...]

2019-09-06T18:04:25+00:00September 6th, 2019|Tags: |

iRhythm Technologies to work with Verily to address challenge of identifying patients with undiagnosed atrial fibrillation

Zio XT iRhythm Technologies has announced a collaboration with Verily; a press release reports that this collaboration aims to bring together iRhythm’s expertise in artificial intelligence (AI) based arrhythmia diagnosis and Verily’s advanced health data analytics technologies to address the millions of patients living with undiagnosed atrial fibrillation. Under the terms of [...]

2019-09-06T17:58:30+00:00September 6th, 2019|Tags: , , |

European Product Design Award for novel device for measuring CO2 in breath

Wideblue, a product design and development consultancy, has won a gold award in the European Product Design Awards for a medical device that it developed for Cambridge Respiratory Innovation Ltd. The device, N-Tidal, is a small battery powered personal capnometer—used to measure the amount of CO2 in exhaled breath. Russell Overend, managing director of [...]

2019-09-06T17:53:25+00:00September 6th, 2019|Tags: , |

Life Image launches “Real World Imaging” to improve effectiveness of real-world evidence programmes for life sciences and AI-led innovation

Life Image has announced the launch of its new Real World Imaging (RWI) offering, with the aim of responding to researcher needs for maturing insights and accelerating drug development decisions. With its digital platform that is powered by industry-leading interoperability standards, according to a press release, Life Image specialises in “living” or evolving datasets [...]

2019-09-06T17:48:45+00:00September 6th, 2019|Tags: , , |

Approvals and refusals: Monday 2 September–Friday 6 September

CE mark approval—Moderato implantable pulse generator system (Orchestra BioMed) Orchestra BioMed has received CE mark approval for its Moderato implantable pulse generator system that is designed to deliver BackBeat Cardiac Neuromodulation Therapy for the treatment of hypertension while also providing standard pacemaker functions. Additionally, the Cardiovascular Research Foundation (CRF) has selected the MODERATO II [...]

2019-09-06T17:45:30+00:00September 6th, 2019|Tags: |

FDA 510(k) clearance for 14-Day Carnation Ambulatory Monitor patch

Bardy Diagnostics has received 510(k) clearance from the FDA for a 14-day version of the Carnation Ambulatory Monitor (CAM), which a press release says is market’s only P-wave centric ambulatory cardiac patch monitor and arrhythmia detection device. Developed to provide clinicians greater flexibility in cardiac monitoring over a longer period, the CAM patch will [...]

2019-09-06T17:44:24+00:00September 6th, 2019|Tags: , , |

CE mark for BackBeat Cardiac Neuromodulation Therapy for hypertension

BackBeat CNT Orchestra BioMed has received CE mark approval for its Moderato implantable pulse generator system that is designed to deliver BackBeat Cardiac Neuromodulation Therapy for the treatment of hypertension while also providing standard pacemaker functions. Additionally, the Cardiovascular Research Foundation (CRF) has selected the MODERATO II clinical study, which evaluated BackBeat [...]

2019-09-06T17:40:53+00:00September 6th, 2019|Tags: , , |

Wireless, in-heart, microcomputer implanted in first UK patient

V-Lap A clinical trial, being conducted at the Queen Elizabeth Hospital (Birmingham, UK), of the world’s first wireless in-heart microcomputer has begun. A press release reports that researchers hope that the ground-breaking technology will dramatically improve the quality of life for people living with heart failure, helping them better manage the condition [...]

2019-09-06T17:33:37+00:00September 6th, 2019|Tags: , |

FDA Breakthrough Device Designation for coronary lithotripsy system

Shockwave Lithotripsy Shockwave Medical has received Breakthrough Device Designation from FDA for its Shockwave intravascular lithotripsy (IVL) system with the Shockwave C2 coronary IVL catheter, which is currently the subject of an Investigational Device Exemption (IDE) study called DISRUPT CAD III. A press release reports that the Shockwave C2 IVL catheter is [...]

2019-09-06T17:29:11+00:00September 6th, 2019|Tags: , , |

Stryker announces definitive agreement to acquire Mobius Imaging & Cardan Robotics

Stryker has announced a definitive agreement to acquire Mobius Imaging and its sister company, GYS Tech (DBA Cardan Robotics) in an all cash transaction of approximately $370 million upfront and up to $130 million of contingent payments associated with development and commercial milestones. The acquisition, a press release reports, provides Stryker’s Spine division with [...]

2019-09-06T17:24:56+00:00September 6th, 2019|Tags: , , , |

Andrew Mullen appointed to board of directors of Creavo Medical Technologies

Andrew Mullen Medical device company Creavo Medical Technologies has appointed its operations director Andrew Mullen to its Board of Directors, which will see him lead on research and development (R&D) and regulatory affairs. A press release reports that Mullen has held the operator directors at Creavo for over a year, where he [...]

2019-09-06T17:20:43+00:00September 6th, 2019|Tags: , , |

Robocath raises €5 million ($5.5M) to support the rollout of its robotic platform in strategic European target markets

Lucien Goffart Robocath, which is developing and commercialising cardiovascular robotic systems (such as R-One) for the treatment of vascular diseases, has raised €5 million ($5.5M) to support the roll out of its robotic platform in strategic European target markets. It has also hired Lucien Goffart as CEO. The €5 million ($5.5M) capital [...]

2019-09-06T17:12:04+00:00September 6th, 2019|Tags: , , |

ESC 2019: Abiomed launches Impella SmartAssist platform

At the 2019 European Society Cardiology (ESC) congress (31 August – 4 September, Paris, France), Abiomed revealed that its Impella CP with SmartAssist technology is now commercially available in Europe. A press release reports that the system is designed to improve patient outcomes with advanced algorithms and simplified patient management. It adds that the [...]

2019-09-01T07:19:33+00:00September 1st, 2019|Tags: , , , |

FDA Breakthrough Device Designation for MagicTouch AVF sirolimus-coated balloon

MagicTouch AVF Concept Medical has been granted Breakthrough Device Designation from the FDA for the MagicTouch AVF, sirolimus-coated, balloon catheter for the management of stenotic lesions of arteriovenous fistulae or arteriovenous graft in haemodialysis treatment of renal failure. The proposed indications for the MagicTouch AVF devices are for it to be used, [...]

2019-09-01T06:59:37+00:00September 1st, 2019|Tags: , , |

FDA Approvals & refusals: 26 August–30 August

Each week, BIBA Briefings summarises the key market approvals of medical devices in Europe and the USA. It also covers recalls, safety notices, and indication withdrawals. This report covers from Monday 26 August to Friday 30 August.  FDA approval—MID-C (ApiFix) ApiFix has received FDA approval, via a Humanitarian Device Exemption (HDE), to market the [...]

2019-09-01T07:02:31+00:00August 30th, 2019|Tags: |

Omar Ishrak to step down as Medtronic CEO next year

Omar Ishrak Omar Ishrak, Medtronic’s chairman and CEO is to retire on 26 April 2020, following the end of the company’s current fiscal year. Also, the Medtronic Board of Directors has announced key leadership appointments as part of its multi-year, leadership succession planning process. A press release reports that these announcements will [...]

2019-09-03T08:16:39+00:00August 30th, 2019|Tags: , |

New MRI technique can identify scar muscles of heart without damaging kidneys

Scientists from the Warwick Manufacturing Group (University of Warwick, Warwick, UK) have developed a new 3D MRI computing technique that involves a numerically stable technique of left ventricle myocardial tracking, a 3D extension of local weighted mean function to transform MRI pixels, and a 3D extension of Hierarchical Template Matching model for myocardial tracking [...]

2019-08-30T16:09:58+00:00August 30th, 2019|

FDA grants 510K clearance for Biobeat wearable watch and patch for monitoring blood pressure

Biobeat’s smartwatch and patch. The FDA has granted a 510K clearance for Biobeat’s patch and watch for measurement of blood pressure, oxygenation and heart rate in hospitals, clinics, long-term care and at home. According to press release, Biobeat’s products enable cloud-based healthcare with connectivity either through a smartphone or a dedicated gateway. [...]

2019-08-30T16:02:03+00:00August 30th, 2019|Tags: , |

ApiFix can commercialise its MID-C system for motion-preserving deformity treatment in the USA

ApiFix has received FDA approval, via a Humanitarian Device Exemption (HDE), to market the minimally invasive deformity correction system for the treatment of progressive adolescent idiopathic scoliosis. A press release reports that ApiFix’s MID-C technology is a posterior dynamic deformity correction system that enables surgeons to perform a unique treatment providing permanent curve correction [...]

2019-08-30T16:02:50+00:00August 30th, 2019|Tags: , , |

Concerns about cyber security and lack of empathy may be a barrier to introducing AI into healthcare

A new study, by Tom Nadarzynski (University of Westminster, London, UK) and others, indicates that that a large proportion of the general public are reluctant to use artificial intelligence (AI) led services for their healthcare, particularly for more serious illnesses. The results of the study come after the UK Government announced £250 million funding [...]

2019-08-30T15:29:45+00:00August 30th, 2019|Tags: , |

AdventHealth opens largest command centre of its kind

Mission Control AdventHealth has opened its new “Mission Control”, which a press release describes as the largest command centre of its kind. Its aim to make clinical operations across the healthcare system as streamlined and efficient as possible. The press release adds that the Mission Control will function like its NASA namesake, [...]

2019-08-30T15:25:17+00:00August 30th, 2019|Tags: , , |

Approvals & refusals: Monday 19 August–Friday 23 August

Each week, BIBA Briefings summarises the key market approvals of medical devices in Europe and the USA. It also covers recalls, safety notices, and indication withdrawals. This report covers from Monday 19 August to Friday 23 August.  FDA Class I recall—delivery system of Sapien 3 Ultra The FDA has issued a Class I recall—which [...]

2019-08-27T15:09:43+00:00August 27th, 2019|Tags: |

Delaware Chancery Court rules in favour of Alphatec CEO Pat Miles

Alphatec (ATEC) has announced today that the Delaware Chancery Court entered summary judgment in favour of its chairman and CEO, Pat Miles—terminating all non-competition and employee non-solicitation claims brought against Miles and Atec by NuVasive. According to a press release, Miles joined ATEC as its executive chairman on 2 October 2017, and assumed the [...]

2019-08-27T15:00:13+00:00August 27th, 2019|Tags: , , , |

FDA Fast Track Designation for cell therapy for disc degeneration

DiscGenics has announced that the FDA has granted Fast Track designation for its investigational cell therapy, IDCT, currently being evaluated in regulator-allowed clinical trials in the USA and Japan for the reduction in pain and disability associated with degenerative disc disease. A press release reports that IDCT is reproducibly manufactured in a cGMP environment [...]

2019-08-27T14:52:44+00:00August 27th, 2019|Tags: , |

FDA Breakthrough Device Designation for the PiCSO impulse system

Miracor Medical has been granted Breakthrough Device Designation by the FDA for its PiCSO Impulse System for treatment of ST-segment elevation myocardial infarction (STEMI) patients. The PiCSO impulse system is designed to clear the coronary microcirculation by intermittently occluding the coronary sinus outflow resulting in improved perfusion of the infarcted area of the heart. [...]

2019-08-27T14:53:44+00:00August 27th, 2019|Tags: , , |

Varian completes purchase from Boston Scientific

Varian has completed its asset purchase of the Boston Scientific portfolio of drug-loadable microsphere and bland embolic bead products for treating arteriovenous malformations and hypervascular tumours. According to a press release, this acquisition expands the portfolio of Varian interventional oncology solutions. Back in July, Varian revealed it had signed an asset purchase agreement to [...]

2019-08-27T15:00:50+00:00August 27th, 2019|Tags: , , , |

FDA recalls delivery system of Sapien 3 Ultra within a week of approving it for low-risk patients

The FDA has issued a Class I recall—which it describes as “the most serious type of recall”—for the delivery system of the Sapien 3 Ultra transcatheter aortic valve implantation (TAVI) system. The recall follows Edwards Lifesciences receiving reports of burst balloons during implantation procedures, and it comes just under a week after the FDA [...]

Approvals & refusals: Monday 12 August to Friday 16 August

Each week, BIBA Briefings summarises the key market approvals of medical devices in Europe and the USA. It also covers recalls, safety notices, and indication withdrawals. This report covers from Monday 12 August to Friday 16 August.  Cardiology FDA approval—Evolut R, Evolut PRO (Medtronic); Sapien 3, Sapien 3 Ultra (Edwards Lifesciences) The FDA has [...]

2019-08-21T15:29:10+00:00August 21st, 2019|Tags: |

Interventional treatment for heart failure receives FDA approval

The FDA has approved the Barostim Neo system (CVRx) for the improvement of symptoms in patients with advanced heart failure who are not suited for treatment with other heart failure devices, such as cardiac resynchronisation therapy. A press release reports that, previously, the FDA gave the device a Breakthrough Device designation because it treats [...]

2019-08-21T15:30:45+00:00August 21st, 2019|Tags: , , |

FDA grants Breakthrough Device Designation to stent for aortic dissection

AMDS delivery system Ascyrus Medical has received Breakthrough Device Designation from the FDA for its Ascyrus Medical Dissection Stent (AMDS) to treat acute Type A aortic dissections. A press release reports that this designation serves as validation of the clinical importance of the AMDS and represents a significant milestone in the continued [...]

2019-08-21T14:58:04+00:00August 21st, 2019|Tags: , , |

FDA Breakthrough Device Designation for Interarterial shunt

V-Wave has announced that the FDA has just granted the company a Breakthrough Device Designation for its interatrial shunt for heart failure. V-Wave’s minimally invasive, implanted interatrial shunt is being evaluated in a global, randomised, controlled, double-blinded, 500 patient pivotal IDE trial called RELIEVE-HF. The study is enrolling advanced heart failure patients with preserved [...]

2019-08-21T14:52:40+00:00August 21st, 2019|Tags: , , |

The Tether fusionless scoliosis device is FDA approved

The Tether Zimmer Biomet has announced FDA approval for The Tether for treatment of scoliosis, providing a fusion-less alternative for young patients requiring surgery. A press release reports that The Tether uses a strong, flexible cord, rather than metal rods, to pull on the outside of a scoliosis curve to initially straighten [...]

2019-08-21T14:45:48+00:00August 21st, 2019|Tags: , , |

Alphatec announces Eric Dasso as executive vice president, Adjunctive Technologies

Alphatec Holdings (ATEC) has announced the appointment of Eric Dasso as executive vice president, Adjunctive Technologies. The Company also announced the appointment of Wyatt Stanfield as Area Vice President, Sales, West, and Timothy Day as Territory Development Manager, Northeast, to further the development of ATEC’s strategic sales channel. Having successfully commercialised products and procedural [...]

2019-08-21T14:44:56+00:00August 21st, 2019|Tags: , , , |

ImageReady MRI for Vercise Gevia deep brain stimulation system gets FDA nod

Vercise Gevia Boston Scientific has announced the FDA approval of its ImageReady MRI labelling for the Vercise Gevia deep brain stimulation (DBS) system to be used in a full-body magnetic resonance imaging (MRI) environment. This system, with the Vercise Cartesia directional lead, is designed to treat the symptoms of Parkinson’s disease by [...]

2019-08-21T14:43:24+00:00August 21st, 2019|Tags: , , , |

CardioMech raises $5m in heavily oversubscribed financing

Rick Nehm CardioMech has closed on a convertible note financing of $5 million, which it says was significantly oversubscribed. The note included investments from experienced MedTech investors and brings the total amount raised for CardioMech to $7.5 million in 2019. Proceeds from the raised funding will be used to further accelerate the [...]

2019-08-21T14:46:15+00:00August 21st, 2019|Tags: , |

Jon Serbousek to become CEO of Orthofix at start of November

Jon Serbousek Orthofix Medical has named Jon Serbousek as president of its Global Spine business (effective 5 August 2019). Serbousek is also to succeeds Brad Mason, the company’s retiring president and Chief Executive Officer (CEO), to be effective 1 November 2019. A seasoned executive with more than 30 years’ experience in the [...]

2019-08-21T14:51:31+00:00August 21st, 2019|Tags: , |

FDA gives green light to four TAVI devices to be used for low-risk patients

The FDA has approved Evolut R, Evolut PRO (Medtronic), Sapien 3 and Sapien 3 (Edwards Lifesciences) for the management of low-risk patients with severe aortic stenosis. The approval follows the publication—in the New England Journal of Medicine—of two studies that showed positive results with these devices in low-risk patients. Prior to the FDA approval, [...]

2019-08-20T15:48:35+00:00August 20th, 2019|Tags: , , , , , , |

FDA Breakthrough Device Designation for sirolimus-coated MagicTouch peripheral balloon

Concept Medical has been granted Breakthrough Device Designation from the FDA for its MagicTouch percutaneous transluminal angioplasty (PTA) device—a sirolimus drug-coated balloon catheter—for the treatment of below-the-knee lesions. Earlier this year, on 30 April 2019, Concept Medical received its first Breakthrough Device for its MagicTouch coronary balloon for the treatment of Coronary Artery Disease [...]

2019-08-21T15:25:34+00:00August 14th, 2019|Tags: , , |

FDA approves new trial of ChEVAS for complex aortic aneurysms

Endologix has received Investigational Device Exemption (IDE) approval from the FDA to commence a new pivotal study to evaluate the safety and effectiveness of the its chimney endovascular aneurysm sealing system (ChEVAS) for the endovascular treatment of complex abdominal aortic aneurysms. A press release reports that the ChEVAS system is an endovascular abdominal aortic [...]

2019-08-14T14:36:40+00:00August 14th, 2019|Tags: , |

AtriCure to buy percutaneous LAA device company SentreHEART

AtriCure–developer of Isolator synergy ablation system for persistent atrial fibrillation—has entered into a definitive agreement to acquire SentreHEART, a privately held developer of percutaneous left atrial appendage (LAA) management solutions (including the LARIAT device). Under the terms of the agreement to acquire SentreHEART, the transaction consideration consists of an upfront payment of approximately $40 [...]

2019-08-14T14:38:27+00:00August 14th, 2019|Tags: , , |

HealthTech Arkansas selects Bardy Diagnostics as one of six “disruptive medtech startups”

HealthTech Arkansas, a healthcare accelerator and investment fund that connects early-stage healthcare companies with disruptive technologies to Arkansas healthcare providers, has selected BardyDx to participate in its 2019 accelerator programme. BardyDx was chosen for its carnation ambulatory monitor (CAM)—the industry's only P-wave centric ambulatory cardiac patch monitor and arrhythmia detection device. HealthTech Arkansas is [...]

2019-08-14T14:23:26+00:00August 14th, 2019|Tags: , , |

First patient enrolled in European study of AccuCinch ventricular repair system

AccuCinch The first patient has been enrolled in the CorCinch EU study, which is a European multicentre clinical evaluation of the AccuCinch ventricular repair system (Ancora Heart) as a treatment for patients with reduced ejection fraction systolic heart failure. This is the second recently initiated study evaluating the AccuCinch system that specifically [...]

2019-08-14T14:24:20+00:00August 14th, 2019|Tags: , |

Private equity firm invests in UK centre performing EVLA for varicose veins

David West A private equity firm, Palatine (Manchester, UK), has announced that it has made a “significant investment” into a UK centre—Veincentre—that provides endovenous laser ablation (EVLA) for the management of varicose veins.  The investment, according to Palatine, is the fourth to be made from the firm’s £100m “Impact Fund” that “targets [...]

2019-08-14T14:08:42+00:00August 14th, 2019|Tags: , |

Medtronic buys Titan Spine in bid to provide the “most comprehensive portfolio”

Medtronic has completed its acquisition of Titan Spine, which has a range of interbody fusion devices that feature unique surface technology. A press release reports that the acquisition provides opportunities to bundle interbodies, screws, rods, biologics, and “enabling” technologies, such as navigation, to develop “integrated procedural solutions”. It adds that Titan Spine will now [...]

2019-08-14T14:05:53+00:00August 14th, 2019|

Siemens Healthineers to acquire Corindus Vascular Robtoics for US$1.1 billion

CorPath GRX Siemens Healthineers has entered into a merger agreement with US-based Corindus Vascular Robotics, which has a portfolio of robotic-assisted vascular interventions. Under the terms of the agreement, Siemens Healthineers will acquire all fully diluted shares of Corindus for US$4.28 per share in cash or US$1.1 billion in total. The transaction [...]

2019-08-09T11:37:00+00:00August 9th, 2019|Tags: , , |

FDA Breakthrough Device designation granted to Aortix heart failure system

Procyrion has received Breakthrough Device designation by the US FDA for its Aortix system. According to a press release, Aortix is a circulatory support device for chronic heart failure patients on medical management who have been hospitalised for acute decompensated heart failure with worsening renal function. Through the Breakthrough Device designation programme, Procyrion can [...]

2019-08-09T11:32:16+00:00August 9th, 2019|Tags: , |

PK Papyrus covered coronary stent selected as finalist in Prix Galien USA awards ceremony for Best Medical Technology

The PK Papyrus covered coronary stent system (Biotronik) has been named a finalist in the 2019 Prix Galien USA Awards Ceremony for Best Medical Technology. PK Papyrus is designed to be used in emergency situations to create a physical barrier to seal perforated coronary arteries without the need for invasive surgery. In September 2018, [...]

2019-08-12T13:19:54+00:00August 9th, 2019|Tags: , , |

New European patent for diagnostic assay for patient selection prior to cardiac cell therapy delivery

BioCardia has announced that the European Patent Office has issued the Company Patent No: 3063172 for “methods of measuring potential for therapeutic potency and defining dosages for autologous cell therapies.” A press release reports that BioCardia’s new patent is for a diagnostic approach for patient selection that identifies a specific biomarker signature in a [...]

2019-08-09T11:23:04+00:00August 9th, 2019|Tags: |

FDA Breakthrough Device Designation for B Braun’s SeQuent Please ReXn drug-coated balloon

The US FDA has granted Breakthrough Device Designation for the SeQuent Please ReX drug-coated balloon catheter (B Braun Interventional Systems) for the treatment of coronary in-stent restenosis. A press release reports that SeQuent Please ReX is the latest generation coronary drug-coated balloon catheter developed by B Braun. Ten years of extensive clinical study evaluations [...]

2019-08-09T11:17:16+00:00August 9th, 2019|Tags: , |

UK consensus statement on renal denervation “strongly encourages” clinicians to tell patients about ongoing trials

In a new consensus statement, the Joint UK Societies (JUKS)—which includes the British Society of Interventional Radiology—say that the evidence for renal denervation is “insufficient” to recommend its routine use in clinical practice. However, they add that they support ongoing clinical trial programmes of renal denervation and “strongly encourage” clinicians to tell their hypertensive [...]

Penumbra Jet 7 reperfusion catheter now available in the USA

Jet 7 Penumbra has announced the US commercial availability of its Jet 7 reperfusion catheter, which has “Xtra Flex” technology. According to a press release, the catheter is used with the Penumbra Engine in the fully integrated Penumbra system—an aspiration-based mechanical thrombectomy system that enables physicians to extract thrombus in acute ischaemic stroke [...]

2019-07-30T14:05:08+00:00July 30th, 2019|Tags: , , |

First patient enrolled in global clinical trial of Peregrine system kit for uncontrolled hypertension

Click edit button to change this text. Peregrine system kit Ablative Solutions has announced the enrolment and randomisation of the first patient in its TARGET BP I global clinical trial, which is evaluating Peregrine system kit for the treatment of patients with uncontrolled hypertension. The Peregrine system kit, which is comprised [...]

2019-07-30T13:55:34+00:00July 30th, 2019|Tags: , , |

Keystone Heart and Vasorum enter distribution agreement for Celt ACD vascular closure device

Keystone Heart has signed a distribution agreement with Vasorum for sales and marketing of the Celt ACD vascular closure device. A press release reports that the Celt ACD is an arterial puncture closure device that has been used in more than 40,000 patients to date with excellent clinical results following percutaneous catheter-based vascular procedures.  [...]

2019-07-22T15:03:09+00:00July 22nd, 2019|Tags: , , |

US FDA approval for fourth-generation MitraClip

MitraClip XTR Abbott has received US FDA approval for fourth-generation version of its MitraClip heart valve repair device (MitraClip G4) to treat mitral regurgitation. This latest version, according to a press release, delivers an expanded range of clip sizes, an alternative leaflet grasping feature and facilitation of procedure assessment in real time [...]

2019-07-22T14:59:03+00:00July 22nd, 2019|Tags: , , |

Stephen Mason becomes CEO of Cardinal Health’s medical segment

Cardinal Health has announced that Stephen Mason, currently president of Cardinal Health at-Home Solutions business, has been promoted to CEO of Cardinal Health’s medical segment. Mason will succeed Jon Giacomin, who will be departing the company in mid-August to assume a CEO position at a privately-held company. A press release states that Mason is [...]

2019-07-22T14:55:27+00:00July 22nd, 2019|Tags: |

Clinical trial to evaluate use of NeuroPace RNS for managing uncontrolled eating in obese patients

A US FDA-approved, closed-loop neuromodulation system (RNS, NeuroPace) for medically refractory focal onset epilepsy is to be evaluated for managing loss-of-control eating in patients with body mass index (BMI) of 45-60 kg/m2 for whom medication and gastric bypass surgery have not been effective treatments and for whom loss-of-control eating is a contributing factor. A [...]

2019-07-22T14:51:00+00:00July 22nd, 2019|Tags: , |

Medtronic partners with Viz.ai to accelerate use of AI software in US stroke centres

Medtronic and Viz.ai—which focuses on applied artificial intelligence (AI) in stroke care—have partnered to accelerate the adoption of Viz.ai's new technology, which is designed to help synchronise stroke care and decrease time to treatment, potentially improving outcomes for patients. Viz.ai's technology uses AI to identify suspected large vessel occlusion strokes and automatically notify specialists. [...]

2019-07-22T14:42:17+00:00July 22nd, 2019|Tags: , |

CE mark for av-Guardian vascular access system

av-Guardian Advent Access has received the CE mark for its av-Guardian vascular access system. A press release reports that the av-Guardian is the world’s first implant technology to pioneer the concept of establishing a “guardian guide-door” to facilitate dialysis needles to optimally access an arteriovenous (AV) fistula, without being in contact with [...]

2019-07-15T13:38:17+00:00July 15th, 2019|Tags: , |

Brexit prompts UL International to cease operation in the UK

UL International (UK) (NB 0843) has taken the decision to cease operation as a Notified Body under the Council Directive, 93/42/EEC concerning medical devices (MDD). This will be effective from 1 September 2019. A press release notes this decision is in response to a potential “no deal” Brexit, explaining that a “no deal” will [...]

2019-07-15T13:34:41+00:00July 15th, 2019|Tags: , , |

Orchestra BioMed completes US $34 million financing to accelerate product pipeline development and advance partnerships

Orchestra BioMed has completed a US$34 million Series B-1 Preferred Stock financing—led by institutional investors Perceptive Advisors, RTW Investments and Soleus Capital with participation from strategic partner Terumo Corporation and existing investors from SternAegis Ventures. Additionally, Orchestra BioMed may receive up to an additional $57 million in follow-on investments from existing shareholders based on [...]

2019-07-15T13:30:55+00:00July 15th, 2019|Tags: , , |

Novel catheters with “mirror” enable operators to see device in vasculature in 3D

IntelliCath © Fraunhofer MEVIS A novel catheter (IntelliCath, Intelligent Catheter Navigation) has been equipped with a special optical fibre containing tiny “mirrors”; these mirrors help operators see how a device moves through a patient’s vasculature, in 3D, during a procedure. Torben Pätz (Fraunhofer MEVIS, Bremen, Germany) and his co-developers have already tested [...]

2019-07-15T13:26:29+00:00July 15th, 2019|Tags: , , |

US FDA 510(k) clearance for intraoperative positioning system

Centerline Biomedical has received 510(k) clearance from the US FDA to market its flagship product, the intraoperative positioning system (IOPS). A press release reports that IOPS is a non-radiation-based surgical navigation system for minimally invasive surgery that leverages anatomical mapping algorithms and electromagnetic tracking technology to provide 3D colour visualisation and guidance in real [...]

2019-07-15T11:55:13+00:00July 15th, 2019|Tags: , |

First patient enrolled in CE mark trial of Cordella pulmonary artery sensor system

A press release reports that the first patient has been enrolled in a prospective, multicentre trial (SIRONA II) of a pulmonary artery pressure sensor system (Cordella sensor, Endotronix), the aim of which is to valuate safety and efficacy of the system in support of its CE mark submission. Wilfried Mullens (Ziekenhuis Oost Limburg, Genk, [...]

2019-07-15T15:21:11+00:00July 15th, 2019|Tags: , |

FDA formally ends its Alternative Summary Reporting programme

Jeffrey Shuren In a statement, published on the its website, the FDA has outlined the steps it is taking to update its Medical Device Reporting (MDR) programme—one of the tools the FDA uses to monitor device performance, detect potential device-related safety concerns or signals and contribute to the benefit-risk assessment of these [...]

2019-07-08T16:18:45+00:00July 8th, 2019|Tags: , |

Varian to buy Boston Scientific’s portfolio of drug-loadable microsphere and bland embolic bead products

Varian has signed an asset purchase agreement to acquire the Boston Scientific portfolio of drug-loadable microsphere and bland embolic bead products for treating arteriovenous malformations and hypervascular tumours. The planned acquisition of the drug-loadable microsphere (Oncozene/Embozene Tandem) and bland embolic (Embozene) bead products, a press release reports, will enable Varian to extend its new [...]

2019-07-08T16:13:34+00:00July 8th, 2019|Tags: , , |

Neuronetics appoints Stephen Furlong as chief financial officer

Neuronetics—a company focused on designing, developing and marketing products that improve the quality of life for patients with psychiatric disorders—has announced that Stephen Furlong will become its new chief financial officer and Secretary, replacing Peter Donato. The company’s first commercial product—the NeuroStar Advanced Therapy System—is a non-invasive and non-systemic office-based treatment that uses transcranial [...]

European Society of Cardiology to hold summit on digital health

The European Society of Cardiology (ESC), which is the world’s largest scientific society of cardiovascular professionals, is to hold the ESC Digital Summit on 5–6 October 2019 (Tallinn, Estonia). The summit will focus on the rapid evolution of digital technology and its impact on the prevention and treatment of heart disease. Some 1,000 stakeholders [...]

2019-07-08T16:03:01+00:00July 8th, 2019|Tags: , |

FDA grants breakthrough device designation to Critical Innovations for its “F.O.A.M” device

Critical Innovations has received FDA breakthrough device designation for its “fast onset abdominal management” (F.O.A.M) device, which is designed to deliver a quickly-expanding foam to tamponade severe internal bleeding in trauma patients. The US Army Medical Materiel Development Activity (USAMMDA), through the Medical Technology Enterprise Consortium (MTEC), under a contract worth over one million [...]

2019-07-08T15:58:02+00:00July 8th, 2019|Tags: |

Celling Spine acquires Link Spine with goal of further developing a cell-centric spinal platform

Celling Spine—a subsidiary of Celling Biosciences—has acquired all the assets of Link Spine, which is a subsidiary of Link Orthopedics. A press release reports that Link Orthopedics is a global leader in orthopaedic technologies and was looking for a company to further develop a comprehensive spinal fusion system focused on facet fixation and minimally [...]

2019-07-08T15:53:25+00:00July 8th, 2019|Tags: , , |

Measuring and monitoring pH may help to prevent tissue damage

The Wideblue device Wideblue has developed a new medical device for Softcell Medical that measures and displays the pH of a patients’ tissue during surgery in real-time. This new pH monitoring system—comprising a pH probe and pH monitor—has been developed to assist with the assessment of patients who have either sustained injuries, [...]

2019-07-01T13:48:45+00:00July 1st, 2019|Tags: , , |

Medtronic completes acquisition of Titan Spine

Medtronic has completed the acquisition of Titan Spine; a definitive acquisition agreement between the two companies was previously announced on 9 May 2019. A Medtronic press release reports that the acquisition of Titan Spine strengthens Medtronic’s position as a leading innovator in procedural solutions for spinal surgery. The press release adds that Titan Spine [...]

2019-07-01T13:42:33+00:00July 1st, 2019|Tags: , , |

Novel Ulisses device aims to preserve and resuscitate vascularised tissue for more than 24 hours

Vascular Perfusion Solutions (VPS) has developed a first-of-its-kind medical device—Ulisses—with the aim of preserving and resuscitating vascularised tissue in both organs and limb for more than 24 hours. A press release reports that, move to the next level of research with the device, VPS launched a GoFundMe campaign to raise funds to advance the [...]

2019-07-01T13:50:10+00:00July 1st, 2019|Tags: , , , |

Jonathon Leipsic receives the 2019 DeHaan Award for Innovation in Cardiology

Jonathon A Leipsic The 2019 DeHaan Award for Innovation in Cardiology has been awarded to Jonathon A Leipsic, who is a professor of radiology and cardiology at the University of British Columbia (Vancouver, Canada). The award includes a US$200,000 grant and Leipsic will present the second Dehaan Award Lecture at the Society of [...]

2019-07-01T13:31:19+00:00July 1st, 2019|Tags: , |

CE mark for BioMonitor III–a next-generation injectable cardiac monitor

BioMonitor III After receiving the CE mark, Biotronik has launched its next-generation injectable cardiac monitor (ICM)—BioMonitor III—onto the European market. A press release reports that the novel device is designed to help patients with irregular heart rhythms by documenting suspected arrhythmia or unexplained syncope with increased clarity. Aiming to improve the accuracy [...]

2019-07-01T13:51:24+00:00June 28th, 2019|Tags: , , , |

CMS’ update to coverage policy for TAVI provides greater flexibility for hospitals and providers

The Centers for Medicare & Medicaid Services (CMS) has finalised its update the US coverage for transcatheter aortic valve implantation (TAVI). It will continue to provide coverage with evidence development when furnished according to an FDA-approved indication. However, it has updated the coverage criteria for hospitals and physicians to begin or maintain a TAVI [...]

2019-06-28T16:03:14+00:00June 24th, 2019|Tags: , , , |

US$170m funding for Acutus Medical

A company providing what a press release calls “next-generation electrophysiology technology solutions” has announced that it now has US$170m financing. The press release reports that this includes a US$100 million Series D equity financing and a US$70 million credit facility. It states that the funding is intended to accelerate commercialisation and facilitate global business [...]

2019-06-28T16:04:06+00:00June 24th, 2019|Tags: , |
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