The Samsung Galaxy Watch has been granted FDA clearance for its Irregular Heart Rhythm Notification feature, which can help detect potential atrial fibrillation, Samsung said Monday.
If you’ve got a Galaxy Watch, you’ll eventually be able to use the feature in the Samsung Health Monitor app to detect an irregular heart rhythm, which can be a warning sign for a major cardiovascular issue like heart failure or stroke. Atrial fibrillation, or AFib, can also be asymptomatic, or silent, meaning you may not be aware that something’s wrong.
The new feature will come to this year’s newest Galaxy Watches first, along with the One UI 5 Watch update. It’ll come to previous versions of the Galaxy Watch at a later time.
There’s a difference between FDA clearance and FDA approval. The former is a lower-level certification affirming that a device is safe and effective and cleared for marketing. The latter is generally used for higher-risk devices and requires extensive clinical data.
Samsung didn’t immediately respond to a request for further comment.
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While Samsung’s feature is welcome news, it won’t be the first wearable maker to enable such a feature. Apple revealed an electrocardiogram feature in 2018 with the release of the Apple Watch Series 4. Experts were somewhat skeptical as to how useful AFib detection features could be for the average Apple Watch user, aged 25 to 34, but the device’s heart rhythm monitoring has been shown to be fairly accurate. And features within the Apple Watch have saved lives.
Google’s Pixel Watch also has an AFib detection feature within the Fitbit ECG app.
Smartwatches continue to be big business. The global smartwatch market is estimated to grow to $64 billion in 2023, according to the Business Research Company. The Apple Watch leads the market with 33.6% market share in the final quarter of 2022, according to Statista. For phone makers, having a compelling smartwatch is critical in keeping people locked into a brand’s ecosystem, according to Techsponential analyst Avi Greengart. It could be a contributing reason as to why iPhone’s iOS surpassed Google’s Android as the top mobile operating system in the US last year.