Following the 2018 Apple Watch, the Samsung Galaxy Watch 3 smartwatch’s electrocardiogram (EKG/ECG) app has also been approved by the U.S. Food and Drug Administration (FDA). Federico Casalegno, Samsung’s senior vice president, excitedly said during the Unpacked 2020 event on August 5 that the feature had just been certified by the U.S. FDA for medical devices.
In an interview with TheVerge, an FDA spokesman said Class III high-risk medical products, such as pacemakers, are highly certified, and Samsung’s ECG applications are Class II low-risk products, the same level as Apple Watch, blood pressure monitors, pregnancy tests, and more.
In fact, as early as May this year, Samsung Galaxy Watch Active 2 has activated the ECG feature in the Korean market, but it is unclear when Samsung plans to officially release the new experience to smartwatch users in the United States.
In addition, the Galaxy Watch 3 has blood pressure and oxygen monitoring, but they are not yet certified and are therefore temporarily unable to be available in the U.S. market.