Finding a watch with certified support for ECG is fairly limited at this stage in Australia. For smart watch users, Apple is leading the charge with official certification from the Theraputic Goods Administration (TGA) for the Apple Watch. Understandably Samsung is keen to get in on this action, and it appears the Galaxy Watch has now been certified for ECG use by the TGA.
Samsung has received certification from the Australian Register of Theraputic Goods (ARTG) for a Medical Device Class IIa using Samsung Health Monitor ECG application on a Samsung Galaxy Watch and Phone on the 21st of July.
The Samsung Health app is used on Galaxy phones, and previous Galaxy Watches including the Galaxy Watch Active 2 and Galaxy Watch 3 – both of which are sold in Australia and include support for ECG in the specs, though this function has been dormant on both devices here in Australia due to lack of certification by the TGA. It’s also possible that this could be certification for the Galaxy Watch 4 which is expected to be announced as part of the Galaxy Unpacked event tonight.
The approval doc does take pains to advise that use of the device to record ECG is ‘not intended to replace traditional methods of diagnosis or treatment’, nor is it ‘intended for users with other known arrhythmias and users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.’ The document also says it’s intended for users 22 years of age and over.
Samsung has not yet announced any updates for any of their Galaxy Watch range here in Australia. Previously Samsung announced an expansion of the ECG function to 31 European countries for the Galaxy Watch Active 2 and Galaxy Watch 3 back in February. Whether this certification includes the Galaxy Watch 3 or Galaxy Watch Active 2, and whether it also includes the yet-to-be-announced Galaxy Watch 4 is something we’ll have to wait just a little longer for.