Samsung Galaxy Watch gets first-ever FDA clearance for sleep apnea detection

Matthew Miller/ZDNET

Health and fitness tracking are the latest rage in smart wearables, and the Samsung Galaxy Watch just cleared a major hurdle in the race to adopt a huge new feature.

For the first time ever, the United States Food and Drug Administration has authorized a sleep apnea detection feature on a smartwatch.

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According to a press release, the feature should be available on the Galaxy Watch series by the third quarter of this year and will be able to detect signs of moderate to severe obstructive sleep apnea by tracking a wearer’s sleep twice over a 10-day window, for more than four hours each time. 

Samsung says the tracking is intended for users aged 22 or older who have not already been diagnosed with sleep apnea. 

One of the key symptoms of sleep apnea is a drop in blood oxygen level because of breathing difficulty. The Galaxy Watch can monitor blood oxygen levels, and if a pattern of drops develops, the user will be notified in the Samsung Health Monitor app, available only on Samsung phones. 

Also: 3 surprising features that sold me on the Samsung Galaxy Watch 6 Classic

Sleep apnea is often undiagnosed and untreated in the early stages, Samsung says, and this feature should “enable more people to proactively spot symptoms of the condition, encourage discovering earlier, and further reduce the possibility of health-related complications.”

Doctors have warned that smartphones and watches might not be reliable when it comes to detecting sleep apnea, but that hasn’t stopped manufacturers, including Apple and Fitbit, from attempting to add the feature. Apple is reportedly working on a similar feature, but that one hasn’t received FDA clearance yet. 

Samsung did add a few warnings about the new feature. It shouldn’t be used to replace traditional methods of diagnosis and treatment by a qualified clinician, and the data provided by this device is not intended to assist doctors in diagnosing sleep disorders. 

Also: Samsung Galaxy Watch 6 Classic vs. Watch 5 Pro: Which smartwatch is best for you?

The company also added that due to market restrictions surrounding medical device registration, sleep apnea detection could be restricted if the user travels to a market where the watch hasn’t been cleared as a medical device.

Sleep apnea detection joins a number of other health-related tracking features on the Galaxy Watch, including blood pressure monitoring, electrocardiogram detection, and irregular heart rhythm notification.


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