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