The FDA grants de novo clearance to HeartFlow's novel system for non-invasive measurement of fractional flow reserve, which CEO Dr. John Stevens calls "the gold standard" for diagnosing and treating coronary disease.
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com's coverage highlights our 3 biggest and most influential stories from the day's news to make sure you're up to date on the headlines that continue to shape the medical device industry.
A pivotal trial of Tryton Medical's side-branch stent fails to meet its non-inferiority endpoint for target vessel failure, although most of the patients in the study fell outside its target parameters.
A pivotal clinical trial of Tryton Medical's side-branch stent, the largest ever conducted on coronary bifurcation lesions, failed to meet its primary endpoint for target vessel failure.
The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.
A new report commissioned by the US Food and Drug Administration recommends a seven-year, multi-step implementation project in order to establish a nationwide postmarket surveillance system for medical devices.