FDA Approves Apple Watch Heart Health Feature As Medical Device Development Tool

The Apple Watch’s strong focus has been on health and wellness for a long time. In a significant development, the FDA lent credence to that message as it has approved the Watch’s atrial fibrillation history feature as a Medical Device Development Tool. Apple took the crown of implementing the first-ever digital health technology to its Apple Watch to qualify for the program. It is tipped to be used in clinical trials, for a start.

Apple Watch Heart Health Feature Approved

According to My Healthy Apple, the qualification means that the Watch is acknowledged to offer a non-invasive way to check estimates of AFib burden. Now let’s jump into what an atrial fibrillation feature does. An electrocardiogram on the Apple Watch deduces whether the user has an irregular heartbeat. After that, an AFib History feature records the wearer’s heart events. It gives an estimate of how frequently their hearts have irregular rhythms. The report explains:

“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 Apple Watch can be used as a biomarker test to help evaluate estimates of AFib burden. According to the FDA, the Apple Watch is now serviceable in clinical studies. It is designed to be used both before and after cardiac ablation devices. Moreover, it can also monitor participant’s weekly estimate of AFib burden. Reports claim that the FDA approved two programs this year. They focus on arrhythmia or irregular heartbeats.

The FDA process is no doubt a tough one. It evaluates supporting proof to determine the accuracy and scientifically plausible measurements within a context. FDA’s approval is a real feather in Apple’s cap. What do you guys think? Do share with us in the comment section.

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