Upgraded Sleep Apnea Feature Now Available on Galaxy Ring Following Regulatory Approvals From US FDA and Korea MFDS

Samsung Electronics today announced that its updated Sleep Apnea feature is now available on Galaxy Watch and Ring. Following United States Food and Drug Administration (FDA) clearance in July, the updated feature has also received approval from Korea’s Ministry of Food and Drug Safety (MFDS). With this update, Samsung becomes the first company in the world to bring sleep apnea risk detection on a smart ring.

The updated Sleep Apnea feature, available through the Samsung Health Monitor app, marks a significant leap forward from its predecessor. The enhanced algorithm analyzes a user’s vitals during sleep in greater depth and now provides insight into the level of breathing disruptions detected — going beyond the previous sleep apnea risk assessment to deliver more comprehensive, meaningful information that helps users better understand their condition, which can lead to productive conversations with healthcare professionals.

Most notably, Samsung is extending sleep apnea risk detection to a smart ring for the first time. Galaxy Ring’s comfortable, lightweight design makes it easy to wear through the night and convenient for sleep measurement, encouraging nightly wear. With the feature’s low data requirement, users can gain meaningful insight into their sleep health from as little as two nights of monitoring within a 10-day period. By offering the feature on both Galaxy Watch and Galaxy Ring, Samsung lets users monitor their sleep health in the way that best fits their lifestyle.

Samsung’s original Sleep Apnea feature previously received groundbreaking U.S. FDA De Novo authorization in February, 2024 — the first of its kind for a wearable device designed to detect signs of moderate to severe sleep apnea. Building on that clinically validated reliability, the updated feature has now also been approved by Korea’s MFDS last October. Samsung will continue to expand the feature’s availability so more people around the world can detect possible signs of sleep apnea and take proactive steps toward better sleep health. This underscores Samsung’s dedication to accessible preventive care, with sleep health serving as a fundamental pillar.

“Samsung has long worked to make sleep health a simple and seamless part of everyday life,” said Jongmin Choi, Head of Health R&D Group, Mobile eXperience (MX) Business, Samsung Electronics. “This approval from Korea’s MFDS, along with our introduction of the world’s first support for a smart ring, reflects our commitment to accessible innovation. We are giving people the tools to help spot possible early signs of sleep apnea and take charge of their wellbeing.”

• The Sleep Apnea feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Wearable and Phone. This feature is intended to detect signs of moderate to severe sleep apnea in the form of significant breathing disruptions in users 18 years and older, over a two-night monitoring period. It is intended for on-demand use and requires two nights of valid data within a 10-day period. This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. ↩︎
• Available on Galaxy Watch 9 running Wear OS 7.0 or higher. Support for Galaxy Watch 7/8 will expand through future software updates. ↩︎