Samsung Galaxy Watch receives FDA authorization for sleep apnea feature

This medical monitoring feature’s approval is the first of its kind for wearable technology.

Samsung Electronics recently announced that its Galaxy Watch was compatible with a new Samsung Health Monitor sleep apnea feature that has received De Novo authorization from the US Food and Drug Administration (FDA).

The wearable technology feature is meant to help detect indications of sleep apnea in a wearer.

The approval given to the app that is compatible with the Galaxy Watch and phone was the first of its kind the FDA has issued. The authorization was granted after the app had received a separate approval last October in Korea by that country’s Minister of Food and Drug Safety (MFDS).

Image of Samsung Galaxy Watch
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The feature makes it possible for users aged at least 22 years and who have not received a sleep apnea diagnosis from a medical professional to be able to identify signs of moderate to severe obstructive sleep apnea (OSA) after being monitored for two nights. OSA is a common chronic sleep condition that is frequently undiagnosed and, as a result, leaves its sufferers untreated.

Using this feature involves wearing a Galaxy Watch for tracking the sleep throughout the night.

Wearers seeking to benefit from the feature need to wear their smartwatches for at least two sleeps of over four hours in length inside a ten-day period.

OSA, if left undiagnosed and untreated, can cause an individual to experience a notably higher risk of certain serious medical conditions such as coronary artery disease, hypertension, cardiac arrhythmia, stroke, and heart failure. The condition causes an individual to stop breathing for periods of time during their sleep. These breathing disruptions also impact oxygen supply, boost daytime fatigue, and hurt sleep quality.

Data from the National Sleep Foundation (NSF) shows that about 25 percent of men and 10 percent of women in the United States experience the condition. The new Samsung health Monitor app on the Galaxy Watch is meant to help wearers to better detect indications that they could have moderate or severe OSA. This could encourage them to consult a doctor who can provide an official diagnosis and recommend treatments to reduce the risk of further medical complications.

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