Samsung Electronics introduced at the moment that the Sleep Apnea function1 on the Galaxy Watch collection — out there by way of the Samsung Well being Monitor app2 — is increasing to 34 European markets,3 in addition to Australia and Singapore, bringing the worldwide whole to 70 markets.4
This progress follows the function’s receipt of CE (Conformité Européenne or European Conformity) marking for the European Financial Space. 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. Moreover, the function was just lately accepted by Australia’s Therapeutic Items Administration and Singapore’s Well being Sciences Authority.
The milestone builds on Samsung’s groundbreaking De Novo authorization from the U.S. Meals and Drug Administration (FDA) — the primary of its sort for a wearable gadget to detect indicators of average to extreme obstructive sleep apnea.5 The Sleep Apnea function was additionally accepted by Korea’s Ministry of Meals and Drug Security, Brazil’s well being regulatory company ANVISA and Well being Canada.
Recognizing the important position 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 usually 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 suitable Galaxy Watch collection fashions and Galaxy smartphones. It’s supposed to detect indicators of average to extreme obstructive sleep apnea within the type of important respiratory 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 recognized with sleep apnea. Customers mustn’t depend on this function as an alternative choice to skilled analysis or remedy by a professional healthcare supplier. The information offered by this gadget can also be not supposed to help clinicians in diagnosing sleep problems.
2 Availability might range by market, service, mannequin or paired smartphone. The function is obtainable on Galaxy Watch4 collection and later fashions operating Put on OS 5.0 or later and should be paired with a Galaxy smartphone operating Android 12.0 or later. As a consequence of regulatory restrictions in acquiring approval and registration as a Software program as a Medical Gadget (SaMD), the function solely works on supported Galaxy Watch series models and Galaxy smartphones bought in markets the place the service is at the moment out there. Service could also be restricted when customers journey to unsupported markets.
3 Availability might range relying on country-specific registration in some European markets.
4 Supported markets embody 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, Eire, 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 Thought-about a typical but severe medical situation, sleep apnea causes somebody to cease respiratory whereas asleep, which may end up in disruptions in oxygen provide, decrease sleep high quality, and different well being issues equivalent to hypertension, cardiac dysfunction, stroke or cognitive dysfunction.
6 The Sleep Apnea function makes use of the BioActive Sensor to measure blood oxygen saturation (SpO₂) throughout sleep. It analyzes adjustments in SpO₂ ranges associated to apnea and hypopnea patterns and estimates the Apnea-Hypopnea Index to tell customers of potential signs.
