The FDA has classified a select recall of Edwards Lifesciences (NYSE:EW) Miller and Fogarty atrioseptostomy catheters over balloon deflation, fragmentation and detachment issues as Class I. Class I designations, the FDA’s most severe, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death. The Miller Balloon catheter […]
Acutus Medical wins expanded CE Mark, FDA nod for AcQMap revisions
Acutus Medical said today it won expanded CE Mark approval in the European Union for its AcQMap contact mapping software and FDA clearance in the U.S. for its second-gen AcQMap system. Carlsbad, Calif.-based Acutus Medical’s AcQMap system is designed to detect and display standard voltage-based and higher resolution charge-source maps, and is able to generate real-time, 3D […]
Cardiac Dimensions touts data from Carillon TMVR device study
Cardiac Dimensions today released results from a trial of its Carillon mitral contour system intended for treating functional mitral regurgitation in patients with heart failure, touting significant reductions in regurgitant volume after implantation. Results from the trial were presented at the German Society of Cardiology annual congress, the Kirkland, Wash.-based company said. The percutaneous Carillon device […]
FDA clears AliveCor’s KardiaMobile for bradycardia, tachycardia monitoring
AliveCor said yesterday that it won expanded FDA 510(k) clearance indications for its KardiaMobile personal ECG device, now cleared for detecting bradycardia and tachycardia. The Mountain View, Calif.-based company’s KardiaBand is a wrist-worn electrocardiogram device previously cleared to detect atrial fibrillation and normal sinus rhythm. “No other consumer ECG device in the world, can tell […]
Boston Scientific wins FDA approval for Lotus Edge TAVR
Boston Scientific (NYSE:BSX) said yesterday that it won pre-market approval from the FDA for its Lotus Edge transcatheter aortic valve replacement for high-risk patients. Marlborough, Mass.-based Boston Scientific touted the device as the only TAVR on the U.S. market designed to be repositioned or recaptured after deployment. The path to PMA wasn’t an entirely smooth one; […]
AtriCure restarts DEEP dual-procedure clinical trial
AtriCure (NSDQ:ATRC) said today that it restarted enrollment in its DEEP clinical trial, touting that the first newly added patient in the trial has already been treated. The Mason, Ohio-based company’s DEEP trial is an FDA investigational device exempt study exploring the safety and efficacy of the company’s dual epicardial and endocardial procedure intended to treat […]
The grim stories behind seven of medtech’s worst failures
Medical devices save or restore thousands of patient lives every year, but the dark side to medtech innovation is increasingly drawing attention. For all the good the industry does, it’s worth remembering that the costs can be high – even fatal – when medical device companies don’t get things right. The examples range from women […]
Edwards Lifesciences closes $98m CAS Medical Systems buyout
Edwards Lifesciences (NYSE:EW) yesterday closed the $98 million acquisition of CAS Medical Systems and its non-invasive brain tissue oxygenation monitoring tech. Irvine, Calif.-based Edwards paid $2.45 per share for Branford, Conn.-based Casmed using cash on hand, for an aggregate value of $98.1 million, Casmed said in a regulatory filing. The deal was announced Feb. 12. The […]
Corindus touts first Japanese CorPath GRX procedures
Corindus Vascular Robotics (NYSE:CVRS) said today that the first Japanese procedures using its CorPath GRX robot-assisted device took place as part of a post-market surveillance study. Waltham, Mass.-based Corindus, which last June won clearance from Japan’s Pharmaceutical & Medical Device Agency for CorPath GRX, inked a distribution deal for Japan in February 2017 that included a […]
Stryker wins FDA PMA, launches Lifepak CR2 AED
Stryker (NYSE:SYK) said yesterday that it launched its Lifepak CR2 defibrillator featuring the LifelinkCentral AED program manager after winning FDA premarket approval for the system. The newly launched Lifepak CR2 AED features new technology including CPRInsight, which allows users to continue chest compressions during ECG analysis and can improve survival outcomes, the Kalamazoo, Mich.-based company said. […]
Biotronik launches PK Papyrus covered coronary stent
Biotronik said today that it’s launching the PK Papyrus covered coronary stent system for acute coronary artery perforations in the U.S. When the FDA granted 510(k) clearance last September, the federal safety watchdog touted it as the first such device to win clearance for that indication in 17 years. About 1% of the 800,000 PCIs […]
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