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.
NuVasive says it ousted 16-year CEO Alex Lukianov over violations of its expense and personnel policies, leading analysts to speculate that an acquisition is now more likely for the spinal implant maker.
UPDATED April 1, 2015, with analysts' comments, share performance.
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.
New guidance from the US Food and Drug Administration explains the role of specialized advisory panels in medical device regulatory issues including classification and marketing authorization determinations.
Here's a look at some of the top mergers & acquisitions stories for medical device companies this week: Medtronic buys hearing aid maker Sophono; The year of the medtech mega-merger; European regulators OK $13B Zimmer-Biomet deal; Uroplasty, Vision-Sciences shareholders OK merger; Philips sells stake in lighting biz for $3B