Apple Watch AFib History Feature Qualified by FDA to Evaluate Medical Devices

The FDA has approved Apple's atrial fibrillation (AFib) history feature on the Apple Watch under its Medical Device Development Tools (MDDT) program. This marks the first digital health technology to achieve such qualification. The AFib History feature, present since 2022, allows users to track the frequency of their heart's irregular rhythms using a photoplethysmography sensor.

The feature is aimed at individuals 22 years and older diagnosed with AFib, providing them with retrospective estimates of their AFib burden. It was cleared by the FDA following a clinical study, validating its use as a biomarker test in clinical studies evaluating cardiac ablation devices. This tool is designed to monitor AFib burden both before and after the use of these devices in clinical settings.