The Apple Watch Ultra 2 is a device that focuses on health and wellness, and it has recently been approved by the FDA as a Medical Device Development Tool for its Atrial Fibrillation history feature. This makes it the first digital health technology to qualify under the MDDT program, allowing it to be used in clinical trials.
The AFib history feature on the Apple Watch records the wearer’s heart events and provides an estimate of how frequently their heart is in an irregular rhythm associated with AFib. This feature uses pulse rate data collected by the Watch’s PPG sensor to identify episodes of irregular heart rhythms consistent with AFib, giving users a retrospective estimate of AFib burden.
With this approval, the Apple Watch can now be used as a biomarker test to help evaluate estimates of AFib burden, making it a valuable tool in monitoring heart health. The FDA’s strict approval process evaluates supporting evidence to determine accuracy and scientific plausibility. This qualification of the Apple Watch Ultra 2 under the MDDT program is a significant milestone for Apple, showcasing the device’s capabilities in health monitoring and its potential in clinical settings.
