Samsung says it has received FDA clearance for smartwatch ECG tracking

While its Galaxy Watch3 device is available now, a launch date for the Samsung Health Monitor app that will enable ECG, blood pressure and blood oxygen saturation tracking is still up in the air.
By Dave Muoio
10:01 am

Alongside yesterday's reveal of the Galaxy Watch3, Samsung announced that it has received regulatory clearance from the FDA for its ECG monitoring app.

But while the watch – which also has built-in sensors enabling blood pressure and blood oxygen saturation – is slated for release on Aug. 6, the company did not say specifically when the new Samsung Health Monitor app that enables these features will be released. What's more, the tech company stressed that the features will be seeing rolling activation across different countries due to the need for individual regulatory clearances.

"As you can imagine, we're working with regulatory agencies to bring both the blood pressure and ECG monitoring to Samsung devices, and I'm excited to announce that we have just received the U.S. FDA clearance for the Samsung ECG Monitor app," Federico Casalegno, SVP and head of experience planning and the Samsung Design Innovation Center, said during yesterday's reveal stream.

The clearance is not yet listed on the FDA's website, although the Verge reports confirmation of the clearance as a Class II product from an FDA spokesperson.

Samsung noted that the watch's health monitoring features are not intended for use in diagnosing health conditions. In addition, the company said its blood pressure monitoring feature should be calibrated every four weeks using a traditional blood pressure cuff.


Atrial fibrillation impacts between 2.7 million and 6.1 million people in the U.S., according to the CDC. Consumer-friendly tools such as a smartwatch ECG can help individuals be more aware of whether or not they should consult a clinician or specialist about their heart health, and potentially empowers individuals to take a more active role in their own care and health behaviors.


Since Samsung's health tracking app was cleared and released in South Korea a few months ago, it's been only a matter of time until Samsung's feature makes the jump to other countries.

Doing so would allow the company to finally have a direct response to Apple, its chief competitor in the consumer smartwatch space. Since the 2018 reveal of built-in ECG with the Series 4 Apple Watch, Apple has spurred other wearable makers such as Withings and Fitbit to pursue ECG features on their products. It's also led to a shift in strategy from products from heart health monitoring device makers Omron and AliveCor.

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