In a first, Apple Watch AFib History gains special FDA qualification

In a first, Apple Watch AFib History gains special FDA qualification

Apple added AFib History to Apple Watch’s features, like ECG readings, in 2022. Photo: Apple For the first time, the U.S. Food and Drug Administration (FDA) qualified a digital technology  — Apple Watch’s AFib History feature — for a special research program. AFib, or atrial fibrillation, is a type of abnormal heart beat associated with … Read more

Apple Watch AFib History Feature Qualified by FDA to Evaluate Medical Devices

Apple Watch AFib History Feature Qualified by FDA to Evaluate Medical Devices

Apple’s atrial fibrillation (AFib) history feature on Apple Watch has been qualified by the FDA under its Medical Device Development Tools (MDDT) program, the first digital health technology feature of its kind to do so. Since 2022, Apple Watch has supported AFib History, which allows users diagnosed with atrial fibrillation to view an estimate of … Read more