medical device

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Not so fast. What really happened with FDA’s clearance of the Apple Watch ECG

By Arthur Brandwood | 11 October, 2018
There’s lots of noise about the very rapid de novo clearances for Apple’s “Irregular Rhythm Notification Feature” (DEN 180042) and ECG App (DEN180044) for the Apple Watch. FDA cleared both...
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Software as Medical Devices (SaMD) Growing Regulatory Trends and Opportunities for Innovators

By Luis Jimenez | 27 September, 2018
With SaMD attracting larger players and devices like the Apple Watch, FDA and regulators globally, are developing frameworks for regulating these more efficiently. On Sept 11th, 2018 Apple obtained FDA...
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FDA gives thumbs up to digital submissions

By Arthur Brandwood | 27 September, 2018
In a proposed rule announced 13 September, US FDA plans to do away with paper submissions. The agency isn’t quite going fully digital yet – you still have to mail...

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