FDA OKs First Medical Device For Use With Apple Watch After 19-Month Review

December 7, 2017 at 6:26 PM
FDA last week approved the first medical device cleared for use with the Apple Watch following a 19-month review process largely due to the complexity and potential risk of the product's software, which can interpret diagnostic tests without any physician involvement. The product, AliveCor's KardiaBand, consistently monitors a user's heart rate, notifies users of potential red flags, takes EKG readings by pressing on the band and will even interpret the readings for patients without the intervention of a health care...

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