Samsung Electronics introduced right this moment that the Sleep Apnea function1 on the Galaxy Watch collection — accessible by the Samsung Health Monitor app2 — is increasing to 34 European markets,3 in addition to Australia and Singapore, bringing the worldwide complete to 70 markets.4
This development follows the function’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 well being, security and environmental safety requirements, reinforcing its management in sleep know-how. Additionally, the function was just lately authorized 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 primary of its type for a wearable system to detect indicators of reasonable to extreme obstructive sleep apnea.5 The Sleep Apnea function was additionally authorized by Korea’s Ministry of Food and Drug Safety, Brazil’s well being regulatory company ANVISA and Health Canada.
Recognizing the vital function of sleep in total well being, Samsung is dedicated to serving to customers enhance sleep high quality by understanding their sleep patterns, offering personalised sleep teaching and optimizing their sleep environments. With the Sleep Apnea function, extra customers can now detect signs6 earlier — serving to to stop well being points related to this widespread but typically undiagnosed situation.
The Sleep Apnea function displays Samsung’s ongoing dedication to offering customers with significant insights to assist wholesome sleep habits. By increasing entry to this FDA-authorized function globally, Samsung is empowering customers worldwide to take proactive steps towards higher sleep well being.
1 The Sleep Apnea function is an over-the-counter (OTC), software-only cellular medical utility working on appropriate Galaxy Watch collection fashions and Galaxy smartphones. It is meant to detect indicators of reasonable to extreme obstructive sleep apnea within the type of important respiration disruptions in grownup customers age 22 and older over a two-night monitoring interval. The function is designed for on-demand use and isn’t supposed for people beforehand identified with sleep apnea. Users shouldn’t depend on this function as an alternative choice to skilled analysis or remedy by a certified healthcare supplier. The knowledge offered by this system can be not supposed to help clinicians in diagnosing sleep problems.
2 Availability might differ by market, service, mannequin or paired smartphone. The function is accessible on Galaxy WatchFour collection and later fashions operating Wear OS 5.zero or later and have to be paired with a Galaxy smartphone operating Android 12.zero or later. Due to regulatory restrictions in acquiring approval and registration as a Software as a Medical Device (SaMD), the function solely works on supported Galaxy Watch series models and Galaxy smartphones bought in markets the place the service is presently accessible. Service could also be restricted when customers journey to unsupported markets.
3 Availability might differ relying on country-specific registration in some European markets.
4 Supported markets embrace 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,…
