Samsung Electronics has secured regulatory approval from the South Korean Ministry of Food and Drug Safety (MFDS) for an advanced AI-powered sleep apnea detection feature on its Galaxy smartwatches. The newly cleared software calculates the exact hourly frequency of breathing disruptions, sorting results into mild, occasional, or frequent categories.
In Plain English: The Clinical Takeaway
- What it does: The Galaxy Watch analyzes sleep data using an AI algorithm to count breathing disturbances per hour, going beyond basic sign detection to grade severity.
- How to use it: Users take two separate five-hour sleep measurements within a 10-day window via the Samsung Health Monitor app.
- Who it is for: Adults aged 18 and older without a prior diagnosis of sleep apnea, though the tool serves only as a monitor and does not replace formal medical diagnosis.
MFDS Approval Expands Wearable Diagnostic Reach in South Korea
Following a clearance by the U.S. Food and Drug Administration (FDA) last July, South Korea’s drug safety regulator cleared the software update on October 28. The tool evaluates sleep disruption levels by monitoring breathing patterns during rest. Users access the feature through the Samsung Health Monitor app installed on compatible Galaxy wearables. To register a reading, individuals must log at least five hours of sleep across two separate nights within a 10-day period.
The update arrives locally in November, rolling out first to the Galaxy Watch Ultra 2, Galaxy Watch 9, and the Galaxy Ring. Subsequent software updates will extend the capability to older hardware models running Wear OS 7.0 or higher, including the Galaxy Watch 7 and Galaxy Watch 8. Meanwhile, baseline sleep apnea sign detection remains accessible on devices running Wear OS 5.0 and later, starting from the Galaxy Watch 4.
Samsung Galaxy Watch gets Korean MFDS approval for sleep apnea detection.<갤럭시 워치 수면 무호흡, 식약처 허가의 의미>1. 삼성이 한국 식약처 허가를 받아 갤럭시 워치의 수면 무호흡 기능을 고도화했다2. 허가가 붙는 순간 손목 센서는 기능이 아니라 의료기기가 된다. 진짜 장벽은…
Cardiovascular and Systemic Risks of Untreated Sleep Apnea
Obstructive sleep apnea is a chronic condition characterized by repeated pauses or reductions in breathing during sleep. These interruptions degrade sleep quality and trigger intermittent hypoxia, a drop in blood oxygen levels that places acute stress on the cardiovascular system.
Jong-min Choi, Senior Managing Director and Head of the Health Development Group at Samsung Electronics' MX Business, noted in a statement that sleep apnea features subtle signs that are difficult to notice during daily routines, emphasizing the role of wearable tech in helping users recognize risk factors early.
Samsung has MFDS approval in South Korea for a more detailed Galaxy Watch sleep apnea analysis.- An AI algorithm counts breathing disturbances per hour and sorts them into 3 levels: mild, occasional, frequent- Previously the watch only flagged signs of moderate to severe sleep… pic.twitter.com/F2E6NllKAJ
| Regulatory Milestone | Regulatory Body | Approval Date |
|---|---|---|
| Initial Clearance | South Korean MFDS | September 2023 |
| De Novo Authorization | U.S. FDA | February 2024 |
| Medical Device Clearance | ANVISA (Brazil) | 2025 |
Contraindications & When to Consult a Doctor
It is not designed to diagnose, treat, or replace professional medical evaluations by a qualified physician or sleep specialist. Individuals experiencing excessive daytime fatigue, loud chronic snoring, witnessed apneas, or gasping episodes during sleep should seek a formal clinical evaluation regardless of smartwatch metrics.
Samsung's Sleep Apnea Software Regulatory Approvals Worldwide
Samsung’s software trajectory began with its initial MFDS clearance in September 2023, followed by a U.S. FDA De Novo authorization in February 2024. In 2025, the technology secured medical device approval from Brazil’s National Health Surveillance Agency (ANVISA). With the latest South Korean clearance, the sleep apnea monitoring capability is now deployed across 84 countries worldwide.
References
- Ministry of Food and Drug Safety (MFDS), South Korea. Regulatory device approvals and software clearances.
- U.S. Food and Drug Administration (FDA). De Novo classification order for software-based sleep apnea notification systems.
- Epidemiological prevalence data on obstructive sleep apnea in adult populations.
