FDA qualifies Apple Watch’s AFib history for use in clinical studies
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 describes using it as a noninvasive way to collect the data both before and after treatment:
Designed to be used as a biomarker test to help evaluate estimates of AFib burden as a secondary effectiveness endpoint within clinical studies intended to evaluate the safety and effectiveness...