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

Close-up of rear side of an Apple Watch with a red sports band on a wood table, with its sensors showing Photo by Vjeran Pavic / The Verge

The Apple Watch’s atrial fibrillation (AFib) history feature, which records and alerts the wearer’s relevant heart events, has been qualified to join the FDA’s Medical Device Development Tools (MDDT) 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.

The FDA announcement ...

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