It’s the second smartwatch to receive that designation.
The Samsung Galaxy Watch 3 includes a heart-monitoring electrocardiogram (ECG) app, which the company says 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 devices that go through extensive testing. It’s not clear when the app will be made available to US users.
The existing Samsung Galaxy Watch Active 2 already had an ECG feature, but it hasn’t been usable in the US. The ECG 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 and blood oxygen monitor, but those features haven’t received clearance and won’t be available in the US.