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# Samsung Wins De Novo for Sleep Apnea Watch, Phone
- URL: https://www.fdaweb.com/samsung-wins-de-novo-for-sleep-apnea-watch-phone/
- Published: 2024-02-09T12:00:00.000Z
- Updated: 2026-09-14T14:22:38.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156327

FDA has granted Samsung Electronics a *de novo* authorization for a sleep apnea feature using a compatible Samsung Galaxy Watch and phone. The sleep apnea feature enables users over age 22 years 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 simply track their sleep twice for more than four hours within a 10-day period,” the company says. “The new 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.”