Samsung’s Galaxy Watch Sleep Apnea Feature Granted FDA Authorization


Samsung has announced that its sleep apnea feature on the Samsung Health Monitor app, designed for compatible Samsung Galaxy Watches (like the Watch 6, that we have reviewed) and Phones, has received De Novo authorization from the United States Food and Drug Administration (FDA) — This makes it the first sleep apnea feature of its kind to be authorized by the FDA, following previous approval by South Korea’s Ministry of Food and Drug Safety (MFDS) in October 2023.

The sleep apnea feature is targeted at users aged 22 and above who have not been diagnosed with sleep apnea, aiming to detect signs of moderate to severe obstructive sleep apnea (OSA) over a two-night monitoring period. OSA is a common and chronic sleep condition often undiagnosed and untreated, causing interruptions in breathing during sleep, leading to lower sleep quality and daytime fatigue, and untreated sleep apnea can increase the risk of cardiovascular diseases.

To use the feature, users need to track their sleep for more than four hours on two separate occasions within ten days; With roughly 25% of men and 10% of women in the U.S. experiencing OSA, this feature is expected to help proactively detect sleep apnea, enabling individuals to seek medical care and reduce the risk of health-related complications.

When will it be available?

The sleep apnea feature is part of Samsung’s commitment to providing Galaxy users with advanced sleep tools. It is set to be available on the Galaxy Watch series in the U.S. via the Samsung Health Monitor app in the third quarter.

Filed in Gadgets >Medical. Read more about Galaxy Watch and Samsung.

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