In a year of huge product debuts from major medical device players, a dark horse was the most-read regulatory story of 2016: Obalon Therapeutics and the weight-loss device it developed won that title after the FDA granted pre-market approval in September.
Diabetes devices were also big news in 2016 on the regulatory front, most notably Medtronic’s MiniMed 670G hybrid closed-loop diabetes management system. Abbott’s FreeStyle Libre Pro device also won favor at the FDA this year.
There was also a pair of firsts this year: Medtronic beat out St. Jude Medical to be first to the U.S. market with a leadless pacemaker, the Micra device, and Abbott’s Absorb bioresorbable coronary scaffold was the 1st fully resorbable stent to win FDA approval.
Speaking of the FDA, the federal safety watchdog issued a spate of new rules and regulations this year and made news on other fronts:
FDA POLICY NEWS
Final FDA rules clarify adverse event reporting for contract manufacturers
FDA, medical device industry strike deal over user fees
FDA officials want a national review system for medical devices
Report finds delays, loopholes in FDA’s adverse event reporting
FDA launches public whistleblower site for ‘regulatory misconduct’
FDA APPROVALS NEWS
Obalon Therapeutics reveals PMA for weight-loss balloon with $75m IPO registration
FDA approves Medtronic’s ‘artificial pancreas’ MinMed 670G hybrid closed loop system
Abbott wins FDA nod for Absorb stent
The post Best of 2016: Top 10 regulatory stories appeared first on MassDevice.
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