FDA confirms Samsung’s Galaxy Watch 3 is cleared for EKG, just like the Apple Watch
The Samsung Galaxy Watch 3 includes a heart-monitoring electrocardiogram (EKG or ECG) app, which has been cleared by the US Food and Drug Administration (FDA). It’s the second smartwatch in the US with this feature; the Apple Watch received clearance for a similar app in 2018.
“I’m excited to announce that we have just received the US FDA clearance for Samsung’s ECG monitoring app,” said Samsung SVP Federico Casalegno in today’s Unpacked event.
The clearance means that the watch can be used as a medical device. It’s not the same as full approval, which is a high standard only given to high-risk Class III devices (like pacemakers) that go through extensive testing. Samsung’s app is a lower risk Class II product, an FDA spokesperson confirmed to The Verge. The Apple EKG app is also Class II — as are pregnancy tests and blood pressure cuffs.
It’s not clear when the Samsung app will be made available to US users.
The existing Samsung Galaxy Watch Active 2 already had an EKG feature, but it hasn’t been usable in the US. The EKG app was cleared and activated in South Korea in May, but it’s not clear if it will be unlocked on the Active 2 for US users.
The Galaxy Watch 3 also has a blood pressure monitor, which is not cleared for use in the US, and a blood oxygen monitor, which Samsung says will be available to US users as a software update later this year.
Update August 5th, 2:38PM ET: Updated to include confirmation from the FDA.
Correction: The blood oxygen monitoring feature will be available in the US later this year. We regret the error.