Galaxy Ring Gets FDA Clearance for Advanced Sleep Apnea Detection

Samsung has announced that an advanced sleep apnea detection feature developed for the Galaxy Ring received clearance from the US Food and Drug Administration (FDA) in July. The company says the feature could give users new clues about why they wake up tired even after a full night in bed.

The feature is available on the ring and also on the Galaxy Watch 9 running Wear OS 7.0 or later. The new version keeps the detection covered by the earlier clearance but adds AI-based identification of how often breathing interruptions occur during sleep.

How it differs from the earlier clearance

Samsung received its first De Novo FDA authorization for sleep apnea detection on the Galaxy Watch and Galaxy Ring in February 2024. De Novo is a regulatory pathway for health products or features that have no existing equivalent on the market and do not pose a safety risk to users. That first clearance covered only the detection of signs of moderate to severe sleep apnea.

The new version continues that detection while also using AI to count breathing disruptions for every hour of sleep. This gives users a more detailed picture based on the frequency of interruptions, rather than one limited to moderate and severe signs.

How the feature works

The Samsung Health Monitor app can deliver a result if the user sleeps at least five hours on two nights within a ten-day period. Once that condition is met, the app tells the user whether they show signs of mild, occasional or frequent sleep apnea.

Samsung stresses that only a physician can formally diagnose sleep apnea. According to the company, the data from the device can help users have more productive conversations with healthcare professionals. In other words, the feature is positioned not as a diagnostic tool but as an early indicator worth raising with a doctor.

Rivals and supported devices

Samsung's smart ring competitors Oura and Superhuman do not offer FDA-cleared sleep apnea detection. Both products can, however, track nighttime disturbances that may point to the condition. Samsung and Oura are also locked in a legal dispute over smart ring patents, and a preliminary ruling is expected soon.

Advanced sleep apnea detection is currently available on the Galaxy Ring and the Galaxy Watch 9 running Wear OS 7.0 or later. It is said to be coming to the Galaxy Watch 7 and Galaxy Watch 8 through software updates later on. Samsung also recently revamped its Sleep Coaching feature so that it works with less data, offering users who want extra help with sleep an option with lower data requirements.