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.
3. Biomet swings to Q3 black
Biomet reported a return to fiscal 3rd-quarter profits, despite a foreign currency hit that pushed its top line down nearly 3%, in what’s likely its last financial release as an independent company.
Warsaw, Ind.-based Biomet, which is due any day now to be acquired by cross-town rival Zimmer, posted profits of $48.8 million on sales growth of 2.6% to $800.9 million for the 3 months ended YY, compared with losses of -$65.9 million during the same period in 2014. Read more
2. TAVI: Direct Flow to put its valve up against Medtronic’s CoreValve
Direct Flow Medical said that it won FDA approval to add a head-to-head comparison with Medtronic’s CoreValve device to a clinical trial of its replacement heart valve.
The FDA’s investigational device exemption for the Salus trial also allows Santa Rosa, Calif.-based Direct Flow to enroll a high-risk cohort, the company said. Direct Flow makes a repositionable and retrievable transcatheter aortic valve implant to treat aortic stenosis. Read more
1. FDA clears Synaptive Medical’s ‘GPS for the brain’ technology
Synaptive Medical gained FDA clearance to start marketing its neurosurgery-specific surgical navigation tech for use in U.S. operating rooms.
The Toronto company said its BrightMatter Guide system cleared this regulatory sign-off after “months of review.” Read more
