Samsung's ECG monitoring app gets FDA approval in the US

Users of the new Galaxy Watch3 will now be able to monitor the rhythm of their heart.
Written by Aimee Chanthadavong, Contributor

Samsung has announced its electrocardiogram (ECG) monitoring app has been given the all-clear by the US Food and Drug Administration (FDA).

Up until now, South Korea was the only country where Samsung's ECG monitoring function had been approved.

Available through the Samsung Health Monitor app when connected to a compatible Galaxy smartphone, the ECG monitor can be used to monitor a user's heart rhythm and scan for signs of irregularities or indication of atrial fibrillation (AFib).

Samsung has debuted the ECG function in the US on its new Galaxy Watch3 and Watch Active2.

Back in 2017, Samsung, along with Apple, Fitbit, and other companies, joined an FDA-led pilot program to speed up approval of healthcare-related apps and service.

"We need to modernise our regulatory framework so that it matches the kind of innovation we're being asked to evaluate, and helps foster beneficial technology while ensuring that consumers have access to high-quality, safe, and effective digital health devices," then-FDA commissioner Scott Gottlieb said at the time.

"These pilot participants will help the agency shape a better and more agile approach toward digital health technology that focuses on the software developer rather than an individual product."

The release of the Galaxy Watch3 with the ECG monitor comes a week after rival Apple announced the launch of its Apple Watch Series 6 with a blood oxygen sensor.

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