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# Apple Watch Qualified for AFib Trial Monitoring
- URL: https://www.fdaweb.com/apple-watch-qualified-for-afib-trial-monitoring/
- Published: 2024-05-02T12:00:00.000Z
- Updated: 2026-09-14T14:29:53.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156908

CDRH has qualified the Apple Watch’s Atrial Fibrillation (AFib) History Feature as a medical device development tool (MDDT) for use 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. The watch feature “opportunistically analyzes pulse rate data collected by the general-purpose Apple Watch photoplethysmography (PPG) sensor to identify episodes of irregular heart rhythms consistent with AFib and provides the user with a retrospective estimate of AFib burden (a measure of the amount of time spent in AFib during past Apple Watch wear),” according to a [CDRH summary document.](https://www.fda.gov/media/178230/download?attachment&ref=fdaweb.com)

The summary document notes that the watch’s weekly estimates of AFib burden generated by the AFib History Feature can be used for comparative analysis across arms of a clinical study. “The AFib History Feature may be used throughout the clinical study to monitor a participant’s weekly estimate of AFib burden in order to compare weekly burden estimates before and after cardiac ablation treatment,” it says. “The AFib History Feature’s utility as a secondary endpoint is not intended to replace the findings of any primary endpoints (i.e., it cannot by itself be used to evaluate the safety and effectiveness of cardiac ablation devices).”