South Korea’s MFDS approves Galaxy Watch sleep apnea feature after FDA clearance

South Korea’s MFDS approves Galaxy Watch sleep apnea feature after FDA clearance
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2026-10-28 11:33:00
Updated
2026-10-28 11:33:00

[Financial News] Samsung Electronics is enhancing the Galaxy Watch sleep apnea feature to analyze the severity of breathing disturbances during sleep in three levels. Moving beyond simply checking whether signs of sleep apnea are present, it will display results categorized by the frequency of breathing disturbances per hour.Analysis of hourly breathing-disturbance frequency; two measurements within 10 days
Samsung Electronics said on the 28th that the enhanced sleep apnea feature, which received approval from the U.S. Food and Drug Administration (FDA) last July, has also obtained authorization from South Korea’s Ministry of Food and Drug Safety (MFDS).The new feature uses an artificial intelligence (AI) algorithm to analyze the number of breathing disturbances per hour during sleep. Users can view the results in three categories: “mild,” “occasional” and “frequent.”The sleep apnea feature is a consumer mobile medical solution that measures and analyzes breathing data during sleep using Galaxy wearable devices. The new feature is available in the Samsung Health Monitor app installed on Galaxy devices. Users can check for signs of sleep apnea after recording two sleep sessions of at least five hours each within 10 days.Starting in November, the new feature will first be available in South Korea on the Galaxy Watch Ultra2, Galaxy Watch9 and Galaxy Ring. It is then expected to roll out through software updates to existing models, including the Galaxy Watch7 and Watch8, running Wear OS 7.0 or later.For use as reference material in consultations with specialists
The existing feature, which checks for the presence of signs, will remain available on Galaxy Watch4 and later models running Wear OS 5.0 or later. Samsung Electronics said wearing the device while sleeping is important for reliably collecting sleep data. According to the company, the Galaxy Ring is lightweight and comfortable to wear, making it well suited to taking measurements during sleep.Sleep apnea is a condition in which breathing repeatedly stops or decreases during sleep. It can reduce sleep quality and lead to complications such as high blood pressure, arrhythmia and stroke, making early detection and management important. Samsung Electronics cited data from the U.S. National Sleep Foundation indicating that about 25% of men and about 10% of women in the United States have sleep apnea, but many are unaware of it.Samsung Electronics noted that the feature does not replace professional medical diagnosis or consultation. It is intended for people aged 18 or older with no history of a sleep apnea diagnosis. The results can be used as reference material to understand sleep patterns and when consulting a specialist.Jong Min Choi, a vice president in the Health Development Group of Samsung Electronics’ Mobile eXperience Division (MX Division), said, “Sleep apnea is a sign that is difficult to recognize in everyday life.” He added, “We will continue to innovate so that users can recognize warning signs in advance and manage their sleep health systematically simply by wearing Galaxy wearables while they sleep.”Samsung Electronics’ sleep apnea feature received approval as a software medical device from the MFDS in September 2023. It subsequently received FDA De Novo approval in February 2024 and medical device approval from Brazil’s National Health Surveillance Agency (ANVISA) in 2025. It is now available in 84 countries. 
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