Cardiac Science issued an urgent field safety notice to announce a voluntary recall of its G3 Elite automated external defibrillator (AED) devices. The Deerfield, Wis.-based company said in the notice that it received field reports saying that its G3 Elite devices’ “rescue ready” status indicator displayed red and the service LED was illuminated. After investigating […]
Abbott wins FDA breakthrough nod for ventricular assist system
Abbott (NYSE:ABT) announced today that it won FDA breakthrough device designation for its in-development fully implantable left ventricular assist system (Filvas). According to a news release, left ventricular assist devices are implanted into the body and powered using an external battery pack or charging port. Abbott’s fully implantable device would require no external components, offering more […]
MIT engineers have created a bionic ‘heart’
Massachusetts Institute of Technology announced that engineers at the institute, along with others elsewhere, have collaborated to develop a bionic “heart” designed to offer a more realistic model for testing artificial valves and other devices. According to a report from MIT News, the device is a real biological heart which had its tough muscle tissue replaced […]
FDA OKs new clinical trial for Abbott’s Amplatzer stroke prevention device
FDA has approved a clinical trial that will pit Abbott’s Amplatzer Amulet stroke prevention device against a newer class of blood thinners that are the present standard of treatment. Officials at Abbott (NYSE:ABT) think data from the new Catalyst trial could alter clinical practice, eliminating the need for some people with atrial fibrillation to take blood […]
Boston Sci issues urgent field safety notice for Maestro cardiac ablation system
Boston Scientific (NYSE:BSX) issued an urgent field safety notice to warn of a firmware installation update for its Maestro 4000 cardiac ablation system after issues with radiofrequency delivery. In June 2018, Boston Scientific notified customers of the potential for the unintended continuation of radiofrequency energy emitted from the device after releasing its foot switch. After releasing […]
These medical device companies provide the most research payments
The worlds largest medical device companies are spending tens of millions of dollars a year on research payments to doctors and teaching hospitals — but the payments only make up a tiny fraction of their budgets. That was a big takeaway from an analysis of Medical Design & Outsourcing‘s annual Big 100 and the most […]
Edwards Lifescience boosts 2020 guidance amid strong TAVR sales
Edwards Lifesciences (NYSE:EW) saw its stock jump in after-hours trading today after the company boosted its 2020 guidance amid positive fourth-quarter TAVR sales. The Irvine, Calif.–based cardio device and critical care monitoring company’s Q4 results were mixed. But there was also the news that worldwide TAVR sales were up 30% year-over-year in Q4, to $763 million, […]
Abbott appears to be ahead in the TMVR race
Abbott (NYSE:ABT) announced today that its Tendyne transcatheter mitral valve implantation system has won CE Mark approval in Europe — touting the approval as a first. Industry insiders consider transcatheter mitral valve replacement as the next big thing after transcatheter aortic valve replacement (TAVR), with a potentially significant market for TMVR. The CE Mark for Tendyne […]
Medtronic gains CE Mark for next-gen ICDs
Medtronic (NYSE:MDT) announced today that it has received the CE Mark for its Cobalt and Crome portfolio of implantable cardioverter-defibrillators (ICD) and cardiac resynchronization 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 […]
Journal editors say study of Abiomed’s Impella pumps limited
This article has been updated with a comment from Abiomed. A medical journal editorial has cast doubt on the findings of a research study that sent shares in Abiomed (NSDQ:ABMD) down sharply in November. The editorial in the journal Circulation said the study’s methodology had several limitations and called for randomized controlled trials (RCTs) to determine […]
Eko AFib and heart murmur algorithms win FDA clearance
Eko announced today that it won FDA clearance for its suite of algorithms that combine with the company’s digital stethoscopes to screen for heart conditions during routine physical exams. The San Francisco-based company develops an artificial intelligence-powered, cloud-based software application designed to analyze electrocardiogram (ECG) and heart sound/phonocardiogram (PCG) data, using signal processing and convolutional […]
MassDevice Network
@MassDevice
LinkedIn
YouTube