Samsung Electronics has received approval from South Korea’s Ministry of Food and Drug Safety (MFDS) for an enhanced sleep apnea feature that uses artificial intelligence to classify the severity of breathing problems during sleep into three levels. The upgrade goes beyond detecting signs of sleep apnea to assess how frequently breathing disruptions occur, and is scheduled to roll out gradually to the Galaxy Watch Ultra 2, Galaxy Watch 9 and Galaxy Ring starting in November.
Samsung announced on the 28th that its sleep apnea feature, available through Galaxy wearable devices, had received approval from South Korea’s MFDS following approval from the U.S. Food and Drug Administration (FDA) in July.
The sleep apnea feature is a consumer mobile medical solution that measures and analyzes breathing data during sleep using Galaxy wearable devices. It allows users to check their breathing patterns while asleep and detect signs of moderate to severe sleep apnea.
The newly approved feature uses an AI algorithm to analyze the number of breathing disturbances per hour during sleep, helping users assess the level of breathing problems rather than simply detecting potential signs of sleep apnea.
Users can view results classified into three levels based on frequency: mild, occasional and frequent. This allows them to monitor their sleep health in greater detail than before.
The new sleep apnea feature is available through the Samsung Health Monitor app, which users can download to compatible Galaxy devices. By recording at least five hours of sleep on two occasions within a 10-day period, users can screen for signs of sleep apnea at an early stage.
The new feature is scheduled to become available in South Korea starting in November on the Galaxy Watch Ultra 2, Galaxy Watch 9 and Galaxy Ring. Samsung plans to gradually extend support to existing models, including the Galaxy Watch 7 and Galaxy Watch 8, through software updates for devices running Wear OS 7.0 or later.
“Sleep apnea can be difficult to recognize in everyday life,” said Choi Jong-min, vice president of the Health Development Group in Samsung Electronics’ Mobile eXperience (MX) business. “We will continue to innovate so that users can identify potential warning signs simply by wearing Galaxy wearables while sleeping and systematically manage their sleep health, a key part of preventive healthcare.”
Meanwhile, Samsung’s sleep apnea feature received Software as a Medical Device (SaMD) authorization from South Korea’s MFDS in September 2023, followed by the FDA’s De Novo authorization in February 2024 and medical device approval from Brazil’s National Health Surveillance Agency (ANVISA) in 2025.
