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: , |

Sapien 3 becomes first TAVI valve to be approved for low-risk patients in both Europe and the USA

Sapien 3 Edwards Lifesciences has received the CE mark for its Sapien 3 transcatheter aortic valve implantation (TAVI) device to be used to manage aortic stenosis in low-risk patients. Both Edwards and Medtronic (with its CoreValve Evolut range) have FDA approval for their devices to be used for low-risk patients in the [...]

2019-11-11T17:30:46+00:00November 7th, 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 [...]

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 raises $50 million in Series B round funding, 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 [...]

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: |