FDA confirms Samsung’s Galaxy Watch 3 is cleared for EKG, just like the Apple Watch
Samsung announced FDA clearance during today's event. 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...