Apple Watch heart health feature gets first-of-its-kind approval

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 had approved the watch’s atrial fibrillation history feature as a medical device development tool.

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The Apple Watch is the first digital health technology to qualify for the program, meaning it can be used in clinical trials to begin with.

According to My Healthy Apple, the rating means the watch is recognized as “providing a non-invasive way to check AFib burden estimates.”

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An electrocardiogram on the Apple Watch deduces whether the user has an irregular heartbeat, called atrial fibrillation. The AFib History feature records the user’s cardiac events, allowing sufferers of the condition to see an estimate of how often their hearts have irregular rhythms.

“The AFib History feature analyzes pulse rate data collected by the photoplethysmography (PPG) sensor on Apple Watch to identify episodes of irregular heart rhythms compatible with AFib and provides the user with a retrospective estimate of AFib burden (a measure of the amount of time spent on AFib during previous Apple Watch use),” 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 can now be used in clinical studies. As the report noted, it means it is “designed to be used…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, focusing on arrhythmias, or irregular heartbeats.

The FDA process is strict 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.

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