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FDA Qualifies Apple Watch's AFib History For Use In Clinical Studies

In a first for "digital health technology," the Apple Watch's atrial fibrillation (AFib) history feature has been approved by the FDA to join the FDA's Medical Device Development Tools (MDDT) program. This means the wearable is now usable in clinical studies. The Verge reports: The FDA announcement...

In a first for "digital health technology," the Apple Watch's atrial fibrillation (AFib) history feature has been approved by the FDA to join the FDA's Medical Device Development Tools (MDDT) program. This means the wearable is now usable in clinical studies. The Verge 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 of cardiac ablation devices to treat."

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