FDA Qualifies Apple Watch AFib Feature for Clinical Trial Use in Cardiac Device Studies
The recent qualification of the Apple Watch’s atrial fibrillation (AFib) history feature by the FDA as a Medical Device Development Tool (MDDT) marks a development in the use of digital health technologies in clinical trials. This feature, which utilizes the photoplethysmography (PPG) sensor of the Apple Watch to monitor heart rhythms and AFib, has been cleared for use as a secondary endpoint in trials assessing the effectiveness of cardiac ablation devices. The Apple Watch’s ability to passively collect data on the amount of time a patient spends in AFib provides a unique advantage for medical device developers. By recognizing this…