Samsung Electronics Receives MFDS Approval for AI Sleep Apnea Analysis
October 30, 2026 · 2 min read
Also published in Português (Brasil)
Samsung Electronics is introducing a feature in South Korea that uses artificial intelligence to analyze the frequency and level of breathing disturbances during sleep.
The company announced on October 28 that its AI based sleep apnea function for Galaxy wearables received approval from the Ministry of Food and Drug Safety, following a previous approval from the United States Food and Drug Administration in July.
This updated feature uses AI algorithms to analyze the number of breathing disturbances per hour during sleep. It categorizes these occurrences into three levels: mild, occasional, and frequent. This expands upon the previous version of the tool, which focused on identifying the presence of moderate to severe sleep apnea signs.
Users can access the feature through the Samsung Health Monitor application. To identify sleep apnea signs, the system requires two measurements of at least five hours of sleep within a ten day period. The service is intended for adults aged 18 and older who have no prior history of sleep apnea diagnosis. It is not a replacement for professional medical diagnosis or consultation, but serves as reference material for users and medical staff.
Starting in November, the feature will first be available in South Korea for the Galaxy Watch Ultra2, Galaxy Watch9, and Galaxy Ring. It will later expand to the Galaxy Watch7 and Watch8 via software updates for devices running Wear OS 7.0 or higher. The Galaxy Ring is highlighted for its lightweight design, which facilitates the collection of long term sleep data.
Samsung Electronics previously received software as a medical device approval from the MFDS in September 2023 and De Novo approval from the FDA in February 2024. It also obtained medical device approval from the Brazilian Health Regulatory Agency in 2025. The sleep apnea function is currently available in 84 countries.