Samsung Galaxy Watch joins Apple Watch, Fitbit with FDA nod for afib-warning feature

Better late than never. A year after Fitbit secured the FDA’s signoff for an algorithm built into its eponymous smartwatches that can spot potential signs of atrial fibrillation—and about half a decade after the Apple Watch did the same—Samsung has achieved the milestone, too.

The Korean tech giant announced the news of its FDA clearance this week. Its version of the irregular heart rhythm notification feature will use the Galaxy Watch’s built-in BioActive Sensor to passively keep an eye on a wearer’s heart rate and, if it detects consistent irregularities, will send an alert suggesting they take an electrocardiogram (ECG).

The Galaxy Watch’s on-demand ECG feature, in turn, was cleared by the FDA in 2020. That’s the same year that Samsung announced the addition of another heart health feature to the wearable—for on-the-go blood pressure monitoring, a feature long coveted by its competitors in the smartwatch space—but the FDA has yet to sign off on its use in the U.S.

Samsung said it will begin adding the irregular heart rhythm notification feature to new models of its Galaxy Watch that are slated for unveiling later this year before retrofitting previous iterations of the wearable with the afib-warning software.

The feature will be included in the upcoming update to the wearable’s operating system, dubbed One UI 5 Watch. It won’t be the only health-related new addition to the software: As Samsung announced earlier this month, it’ll also debut a new “sleep insights” platform, a heart-rate-monitoring feature specifically for runners and a handful of updates to its fall detection and other emergency-related technologies.

The heart rhythm alerts are only cleared for use by Galaxy Watch wearers who are at least 22 years old, and Samsung warned that the feature may not catch every instance of irregular heart rhythm that could point to afib.

The Apple Watch was responsible for paving the path that Samsung is now following. In 2018, it scored a pair of FDA clearances—the wearable’s first—for both a built-in ECG feature and an algorithm that would work in the background to continuously check for signs of afib.

Google-owned Fitbit has been hot on Apple’s tail ever since: It landed FDA OKs of its own first for an integrated ECG in late 2020, and then, last spring, for a feature that passively checks for afib around the clock.

But Apple has already leaped ahead since then. It landed another FDA nod last June for a software update dubbed “AFib History,” which keeps track of all detected instances of an Apple Watch wearer’s irregular heart rhythm and compiles them into a weekly report that not only summarizes their afib frequency but also factors in how lifestyle factors may be impacting their heart health based on other tracked data spanning sleep, activity and alcohol consumption.