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Samsung wins de novo nod for watch that detects sleep apnea

The FDA created special controls that provide a path to market for other developers of over-the-counter devices.

Samsung Electronics has received de novo authorization for a smartwatch and associated mobile app that can detect signs of sleep apnea.

The Food and Drug Administration authorized the Samsung Galaxy Watch for the detection of signs of moderate to severe obstructive sleep apnea (OSA) in people aged 22 years and older.

The new feature gives Samsung an edge over competitor Apple, who also sought to add a sleep apnea feature to its smartwatch, according to a report from Bloomberg.

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