Samsung Expands Global Reach of Sleep Apnea Feature on Galaxy Watch With CE Marking Certification in Europe

Samsung Electronics Co., Ltd. today announced that the Sleep Apnea feature¹ on the Galaxy Watch series, available through the Samsung Health Monitor app², is officially expanding its availability to include European markets, along with Australia and Singapore.

This growth has been driven by the feature securing CE (Conformité Européenne, European Conformity) marking for the European Economic Area (EEA). Additionally, the feature has recently been approved by the Therapeutic Goods Administration (TGA) in Australia and Health Sciences Authority (HSA) in Singapore.

The milestone follows Samsung’s groundbreaking United States Food and Drug Administration (FDA) De Novo authorization. Moreover, the Sleep Apnea feature has also received regulatory approval from Korea’s Ministry of Food and Drug Safety (MFDS), Brazil’s Health Regulatory Agency (ANVISA) and Health Canada, Canada’s regulatory authority.

Recognizing the critical role of sleep in overall health, Samsung is committed to enhancing users’ sleep quality by understanding their sleep patterns, providing personalized sleep coaching and optimizing sleep environments.

When it comes to your health, small changes can make a big difference, starting with a good night’s sleep. The quality of sleep we get every night has a significant impact on our physical and mental well-being, and the Sleep Apnea feature continues Samsung’s commitment to provide Galaxy users with the best possible tools to improve healthy sleep habits. By expanding access to its Sleep Apnea 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 a compatible Samsung Galaxy Watch and Phone. It is intended for on-demand use, to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions over a two-night monitoring period. Not intended for use by people under 22 years or, or who have previously been diagnosed with sleep apnea, are pregnant, or have any of the following conditions: Parkinson’s, tremor, Periodic Leg Movement During Sleep, congestive heart failure, atrial fibrillation, chronic obstructive pulmonary disease, chronic bronchitis, emphysema, or pulmonary fibrosis. Users should not interpret or take clinical action based on the device output without consultation with a qualified healthcare professional. Not intended to replace traditional methods of diagnosis or treatment, and the data provided by this feature is not intended to assist clinicians in diagnosing sleep disorders. Results displayed are for informational purposes only. Please consult a medical professional for advice. UI may vary depending on the software version, country, or region. For full terms and conditions of use, please refer to the Instructions for Use on your device. Sleep Apnea feature has received a Medical Device License from Health Canada as of September 2024.

² Availability may vary by market, carrier, model, or a paired smartphone. Available on Galaxy Watch4 series and later models. The watch requires the Wear OS 5.0 version or later and must be paired with a Samsung Galaxy smartphone with Android 12.0 or later. Due to market restrictions in obtaining approval/registration as a Software as a Medical Device (SaMD), it only works on watches and smartphones purchased in the markets where service is currently available (however, service may be restricted when users travel to non-service markets).