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Q3 US Device Approvals Snapshot: Apps Up, Original PMAs Down

 
• By David Filmore

Mobile apps made major headway into the world of US FDA regulation in the third quarter, with de novo go-aheads for two Apple Watch heart-rhythm apps and the first FDA approval of a smartphone app to support contraception. Meanwhile, original PMA-approval volumes continue to lag in 2018. Here's an infographic to spotlight US device approval trends during the third quarter, July through September.

FDA approved background, 3D rendering, blue street sign

Smart devices and apps have been targeting health care for years, and US FDA has been making a big push to build a framework and expertise to regulate the space. Those two lines of effort met in a big way last quarter, with the first set of high-profile direct-to-consumer mobile apps cleared by FDA.

The Apple Watch apps intended to monitor for atrial fibrillation gained FDA go-ahead in September. (Also see "FDA's Speedy Apple Watch De Novos Raise Questions For Industry" - Medtech...

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