AFib History Apple Watch Feature Qualified for Use in Medical Device Development

The Apple Watch’s atrial fibrillation (AFib) history feature is now qualified as the first digital health technology under the FDA’s Medical Device Development Tools (MDDT).

The feature works by analyzing pulse rate data collected by the standard Apple Watch photoplethysmography (PPG) sensor to identify episodes of irregular heart rhythms consistent with AFib.The history feature provides retrospective estimate of AFib burden — a measure of the amount of time spent in AFib during past Apple Watch wear.

The value of the tool, the FDA says, is that it provides a non-invasive way to check estimates of atrial fibrillation (AFib) burden within clinical studies — used as a biomarker to help evaluate estimates of AFib burden before and after cardiac ablation treatment.

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