Apple Watch Ultra 2 is one of the devices with AFib history.
The Apple Watch has long touted its strong focus on health and wellness. And the FDA lent credence to that message when it announced this week that it has approved the Watch’s atrial fibrillation history feature as a Medical Device Development Tool.
The Apple Watch is the first-ever digital health technology to qualify for the program, which means it can be used in clinical trials, for a start.
According to My Healthy Apple, the qualification means that the Watch is recognized “to provide a non-invasive way to check estimates of AFib burden.”
An electrocardiogram on the Apple Watch deduces whether the user has an irregular heartbeat, called atrial fibrillation. The AFib History feature records the wearer’s heart events, allowing those with the condition to view an estimate of how frequently their hearts have irregular rhythms.
“The AFib History feature analyzes pulse rate data collected by the Apple Watch photoplethysmography (PPG) sensor to identify episodes of irregular heart rhythms consistent with AFib and provides the user with a retrospective estimate of AFib burden (a measure of the amount of time spent in AFib during past Apple Watch wear),” the report explains.
This means the Watch can be used as a biomarker test, “to help evaluate estimates of AFib burden.”
The FDA said the Apple Watch is now usable in clinical studies. As the report noted, it means it is “Designed to be used … both before and after cardiac ablation devices, to monitor a study participant’s weekly estimate of AFib burden.”
Two programs have been approved for this year, with a focus on arrhythmia, or irregular heartbeats.
The FDA process is a stringent one and evaluates supporting evidence to determine accuracy and whether it can be used for scientifically plausible measurements within a context. As such, it’s a real feather in Apple’s cap.