A breakthrough for the Apple Watch

FDA approves its atrial fibrillation feature as a pioneering medical tool

Image credit: Image Creator from Microsoft Designer/DALL.E and Canva

The U.S. Food and Drug Administration (FDA) has recognized the Apple Watch's Atrial Fibrillation History Feature as a qualified Medical Device Development Tool (MDDT). This tool can assess the burden of atrial fibrillation (AFib), a type of arrhythmia or irregular heartbeat, in clinical studies.

Key attributes include:

• It stands as the first digital health technology to be qualified under the MDDT program, offering a non-invasive method to monitor AFib burden estimates in clinical research.

• It is specifically designed for use as a biomarker test to aid in assessing AFib burden estimates, making it a valuable secondary effectiveness endpoint in clinical trials that evaluate the safety and effectiveness of cardiac ablation devices.

• It is intended for use throughout the clinical trial process, both before and after the application of cardiac ablation devices, allowing for continuous monitoring of a participant's weekly AFib burden estimate.