Samsung Electronics announced today that the Sleep Apnea feature1 on the Galaxy Watch series — available through the Samsung Health Monitor app2 — is expanding to 34 European markets,3 as well as Australia and Singapore, bringing the global total to 70 markets.4
This growth follows the feature’s receipt of CE (Conformité Européenne or European Conformity) marking for the European Economic Area. The CE marking affirms that Samsung meets the European Union’s health, safety and environmental protection standards, reinforcing its leadership in sleep technology. Additionally, the feature was recently approved by Australia’s Therapeutic Goods Administration and Singapore’s Health Sciences Authority.
The milestone builds on Samsung’s groundbreaking De Novo authorization from the U.S. Food and Drug Administration (FDA) — the first of its kind for a wearable device to detect signs of moderate to severe obstructive sleep apnea.5 The Sleep Apnea feature was also approved by Korea’s Ministry of Food and Drug Safety, Brazil’s health regulatory agency ANVISA and Health Canada.
Recognizing the critical role of sleep in overall health, Samsung is committed to helping users improve sleep quality by understanding their sleep patterns, providing personalized sleep coaching and optimizing their sleep environments. With the Sleep Apnea feature, more users can now detect symptoms6 earlier — helping to prevent health issues associated with this common yet often undiagnosed condition.
The Sleep Apnea feature reflects Samsung’s ongoing commitment to providing users with meaningful insights to support healthy sleep habits. By expanding access to this FDA-authorized feature globally, Samsung is empowering users worldwide to take proactive steps toward better sleep health.
1 The Sleep Apnea feature is an over-the-counter (OTC), software-only mobile medical application operating on compatible Galaxy Watch series models and Galaxy smartphones. It is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users age 22 and older over a two-night monitoring period. The feature is designed for on-demand use and is not intended for individuals previously diagnosed with sleep apnea. Users should not rely on this feature as a substitute for professional diagnosis or treatment by a qualified healthcare provider. The data provided by this device is also not intended to assist clinicians in diagnosing sleep disorders.
2 Availability may vary by market, carrier, model or paired smartphone. The feature is available on Galaxy Watch4 series and later models running Wear OS 5.0 or later and must be paired with a Galaxy smartphone running Android 12.0 or later. Due to regulatory restrictions in obtaining approval and registration as a Software as a Medical Device (SaMD), the feature only works on supported Galaxy Watch series models and Galaxy smartphones purchased in markets where the service is currently available. Service may be restricted when users travel to unsupported markets.
3 Availability may vary depending on country-specific registration in some European markets.
4 Supported markets include Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, Christmas Island, Cocos (Keeling) Islands, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, Iceland, Ireland, Italy, Kuwait, Latvia, Lithuania, Luxembourg, Malta, Mauritius, Mayotte, Mexico, Netherlands, Nicaragua, Norfolk Island, Norway, Oman, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Réunion, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom, United States, Venezuela, Vietnam and Yemen.
5 Considered a common yet serious medical condition, sleep apnea causes someone to stop breathing while asleep, which can result in disruptions in oxygen supply, lower sleep quality, and other health complications such as hypertension, cardiac disorder, stroke or cognitive disorder.
6 The Sleep Apnea feature utilizes the BioActive Sensor to measure blood oxygen saturation (SpO₂) during sleep. It analyzes changes in SpO₂ levels related to apnea and hypopnea patterns and estimates the Apnea-Hypopnea Index to inform users of potential symptoms.
