The Apple Watch Ultra 2 is a device with a history of detecting Atrial Fibrillation (AFib). Recently, the US Food and Drug Administration (FDA) qualified the AFib history feature on the Apple Watch as a Medical Device Development Tool. This marks a significant milestone as the Watch becomes the first digital health technology to qualify for this classification.
The AFib history feature on the Apple Watch records heart events and allows users diagnosed with atrial fibrillation to estimate how frequently their heart is in an irregular rhythm. When users take an ECG on the Apple Watch, it is able to determine whether they have AFib or not. This feature analyzes pulse rate data collected by the Apple Watch sensor and provides retrospective estimates of AFib burden. This information can be used as a biomarker test to evaluate estimates of AFib burden over time.
With FDA approval, the Apple Watch can now be utilized in clinical trials related to arrhythmia or irregular heartbeats. This approval is a testament to Apple’s dedication to incorporating advanced health features into their products. The FDA process is thorough and evaluates supporting evidence to ensure accuracy and reliability. This recognition serves as a significant achievement for Apple in the health technology space.