FDA qualifies Apple Watch’s AFib history for use in clinical studies

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The Apple Watch’s AFib detection history feature is now accepted under the Medical Device Development Tools (MDDT) program by the FDA.

The Apple Watch’s atrial fibrillation history feature, which records and alerts the wearer’s relevant heart events, has been qualified to join the FDA’s Medical Device Development Tools program — a first for a “digital health technology.” That means the Apple Watch is now usable in clinical studies that need estimated data on how much time the wearer spent in atrial fibrillation while wearing the device, 9to5Mac reports.

Features such as fall detection and car crash detection have been credited with saving lives. Apple often cites Apple Watch customer anecdotes in its marketing who say they visited their doctors after receiving heart-related alerts on their wrists — which potentially saved their lives. However, added anxiety from extra data could also be detrimental.

 

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