Samsung's sleep apnea feature just got FDA approval - will launch later this year

The Galaxy Watch will officially be able to detect signs of the condition
Samsung samsung sleep apnea fda approval
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Samsung has announced that its sleep apnea detection feature has been approved for use by the US Food & Drug Administration - a vital step in the company's quest to solidify the Galaxy Watch a serious health tracker.

The feature was first revealed back in October, with Samsung receiving approval from the Korean Ministry of Food and Drug Safety (MFDS), and it's now cleared another major hurdle. 

Smartwatches from Samsung (and the rest of the industry) have long been able to track SpO2 levels, the metric most often used to spot signs of sleep apnea, but, until now, companies haven't been able to market themselves as actually able to detect the condition. 

With this 'De Novo' classification from the FDA, that's now changed. And it means Samsung can now spell out to users that it can detect sleep apnea on the Galaxy Watch. Considering the National Sleep Foundation (NSF) estimates roughly 25% of men and 10% of women in the US suffer from the condition, too, this is no small feat. 

WareableGalaxy Watch 6 sleep apneaThe Galaxy Watch 6 will likely support the feature later this year

It's not clear exactly how the feature works, but the fine print of its announcement blog post would suggest that breathing rate tracking is a major part of the health tool. The watch can detect signs "in the form of significant breathing disruptions", Samsung says.

There are a few caveats to it, as well. This isn't a catch-all sleep apnea detector - and Samsung is still urging users (again, in the fine print) not to use it as a replacement for "traditional methods of diagnosis or treatment by a qualified physician".

Instead, the Korean giant says the feature can only detect signs of sleep apnea in people aged 22 and over who haven't previously been diagnosed with the condition, with the smartwatch grading the user as having 'moderate' or 'severe' obstructive sleep apnea.

The only real requirement for proper detection is that users must track their sleep for more than four hours over two nights - and those nights have to occur within ten days. 

Samsung doesn't make clear which Galaxy Watch devices will be able to take advantage of the upcoming feature, but does note that it'll be landing via the Samsung Health Monitor app in the US in Q3 (1 July - 30 September).

That means it's almost certain to join the new health features Samsung has already teased when the Galaxy Watch 7 and Galaxy Ring are officially launched around the same period. 

For now, we'll have to wait for more in-depth details to emerge regarding the feature, but it's one we're looking forward to getting to grips with later this year.

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Conor Allison


Conor moved to Wareable Media Group in 2017, initially covering all the latest developments in smartwatches, fitness trackers, and VR. He made a name for himself writing about trying out translation earbuds on a first date and cycling with a wearable airbag, as well as covering the industry’s latest releases.

Following a stint as Reviews Editor at Pocket-lint, Conor returned to Wareable Media Group in 2022 as Editor-at-Large. Conor has become a wearables expert, and helps people get more from their wearable tech, via Wareable's considerable how-to-based guides. 

He has also contributed to British GQ, Wired, Metro, The Independent, and The Mirror. 

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