The US Food and Drug Administration has granted a De Novo authorization to a smartwatch developer for an over-the-counter feature to provide a notification of the risk of sleep apnea in users who have not been previously diagnosed.

The sleep apnea feature on the Samsung Health Monitor app, developed by Samsung Electronics, has received authorization from the FDA. The over-the-counter feature, which detects signs of sleep apnea using a compatible Samsung Galaxy Watch and phone, is the first of its kind to be authorized by the FDA following previous approval by Korea’s Ministry of Food and Drug Safety in Korea, announced last October.

The sleep apnea feature enables users over age 22 who have not been diagnosed with sleep apnea to detect signs of moderate to severe obstructive sleep apnea (OSA) over a two-night monitoring period. To utilize the feature, users can track their sleep twice for more than four hours within a 10-day period.

The feature on the Samsung Health Monitor app is expected to help more people proactively detect moderate or severe forms of OSA, and, as a result of the detection, seek medical care to reduce the possibility of health-related complications, according to a release from Samsung. 

“With the sleep apnea feature, Samsung is taking the next step in its ongoing commitment to provide Galaxy users with the best possible sleep tools to improve their sleep health habits,” says the company in the release. 

This device uses software algorithms to analyze input sensor signals and provide a risk assessment for sleep apnea. It is not intended to provide a standalone diagnosis, replace traditional methods of diagnosis (eg, polysomnography), assist clinicians in diagnosing sleep disorders, or be used as an apnea monitor. The software-only feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician.

The feature will be available on the Galaxy Watch series in the US via the Samsung Health Monitor app in the third quarter.

Photo caption: Galaxy Watch

Photo credit: Samsung Electronics