Connect with us

Tech

Apple Watch Heart Health Feature Wins First Of Its Kind Approval

Published

on

Apple Watch Heart Health Feature Wins 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 has approved the Watch’s atrial fibrillation history feature as a Medical Device Development Tool.

ForbesApple Watch Ultra 3: Almost No Upgrade Coming, Insider’s Latest Leak Says

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.”

ForbesiPad 2024: Apple Will Reveal Big AI Plans In Days, Tim Cook Confirms

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.

ForbesApple Confirms Widespread iPhone Changes Coming To Millions Of iPads

Continue Reading