FDA Qualifies Apple Watch’s AFib Tracker for Use in Clinical Studies

Apple Watch’s atrial fibrillation (AFib) history feature, which records and alerts the user’s relevant cardiac events, was qualified to join the FDA’s Medical Device Development Tools (MDDT) program – a breakthrough in a “digital health technology.” This means the Apple Watch can now be used in clinical studies that need estimated data on how long a user spent in atrial fibrillation while wearing the device. 9to5Mac reports.

The FDA announcement describes its use as a non-invasive way to collect data before and after treatment:

Designed to be used as a biomarker test to help evaluate estimates of the burden of AFib as a secondary efficacy endpoint in clinical studies designed to evaluate the safety and effectiveness of cardiac ablation devices to be treated.

Apple has long considered its watch a lifesaver for those who use it. Features like fall detection and car accident detection have been credited with saving lives. Apple often cites anecdotes in its marketing from Apple Watch customers who say they visited their doctors after receiving heart-related alerts on their wrists — which potentially saved their lives. However, the additional anxiety caused by additional data can also be harmful.

The FDA previously granted authorization for two functions of the Apple Watch as a direct-to-consumer wearable device with an electrocardiogram and to notify you if you have an irregular heartbeat, starting with the Series 4 in 2018. It also specified that the apps “are not intended to replace traditional methods of diagnosis or treatment” – if you feel unwell or have questions, you should still count on a real doctor. The Apple Watch does not diagnose illnesses, and one study suggested that treatments for illnesses are not suitable for the typical Apple Watch user.