The popular Apple Watch qualified for the U.S. Food and Drug Administration’s (FDA) Medical Device Development Tools program on May 1 due to its Atrial Fibrillation (AFib) History feature. The smartwatch is the first digital health device to qualify for the agency’s program, enabling researchers to use the feature in clinical trials to detect heart arrhythmias.
The FDA announced that the watch’s feature is a noninvasive way to collect AFib data, adding that it is “designed to be used 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.”
