Samsung Gets MFDS Approval for AI Sleep Apnea Detection with 3-Level Severity Grading
Samsung announced its enhanced AI sleep apnea feature received medical device approval from South Korea's MFDS, introducing three-level severity analysis for Galaxy wearables starting November.
Samsung Electronics announced on October 28 that its upgraded sleep apnea detection feature has obtained medical device approval from South Korea's Ministry of Food and Drug Safety (MFDS). The feature utilizes artificial intelligence algorithms to precisely analyze the number of breathing disturbances per hour during sleep, upgrading the results from simple presence/absence detection to three severity levels: mild, occasional, and frequent.
The feature had previously received approval from the U.S. Food and Drug Administration (FDA) in July this year. The newly approved functionality is scheduled to launch in South Korea next month (November), initially available on the Galaxy Watch Ultra2, Galaxy Watch9, and Galaxy Ring. The Galaxy Ring is noted for its lightweight design and comfort, which aids in stable sleep data collection.
Samsung stated it will gradually expand the feature to existing models like the Galaxy Watch7 and Watch8 running Wear OS 7.0 or higher via future software updates. Users need to measure via the Samsung Health Monitor app; detecting signs requires at least two measurements of over five hours of sleep within ten days.
Untreated sleep apnea can lead to hypertension or stroke. Choi Jong-min, Executive Vice President of the Health Development Group at Samsung's Mobile eXperience (MX) Division, emphasized the goal of helping users recognize hard-to-detect risk signals in daily life. Currently, Samsung's sleep apnea feature is available in 84 countries worldwide, including South Korea, the US, and Brazil.