FDA Qualifies Apple Watch AFib Feature for Clinical Research Use

The Apple Watch's AFib history feature has been officially qualified by the FDA to be used in clinical studies, marking a significant step for digital health technologies.

The FDA's Medical Device Development Tools program now includes the Apple Watch's AFib feature, allowing it to be used to assess atrial fibrillation burden in clinical studies.
This marks the first time a digital health technology has been qualified under the MDDT program.
The qualification is based on the Apple Watch's ability to provide non-invasive estimates of AFib burden, which can be crucial for cardiac research.
Despite the qualification, real-world application may be limited due to ongoing legal issues concerning Apple's use of pulse oximeter technology.
Past endorsements of the Apple Watch for AFib detection were more limited, making this new qualification a more significant approval.