This report has been updated with comments from Edwards Lifesciences, Madris Tomes and the FDA. Abbott (NYSE:ABT) and Edwards Lifesciences (NYSE:EW) may have mislabeled patient deaths as injuries or device malfunctions in hundreds of FDA adverse event reports involving their transcatheter aortic or mitral valve replacement devices, according to a new study. The study by JAMA […]
deviceevents
How is the partial government shutdown affecting FDA?
The FDA is not accepting new medical device registration applications funded by user fees during the ongoing partial federal government shutdown. The medtech industry hasn’t been complaining about it yet, but time will tell, according to some experts. Applications for devices covered by the agency’s 510(k) and Premarket Approval (PMA) processes accepted before Dec. 22 […]