Samsung Electronics introduced in the present day that the Sleep Apnea function1 on the Galaxy Watch collection — out there by means 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 development 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 lately permitted 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 system to detect indicators of reasonable to extreme obstructive sleep apnea.5 The Sleep Apnea function was additionally permitted by Korea’s Ministry of Meals and Drug Security, Brazil’s well being regulatory company ANVISA and Well being 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 frequent but usually undiagnosed situation.
The Sleep Apnea function displays Samsung’s ongoing dedication to offering customers with significant insights to help 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 cell medical software working on appropriate Galaxy Watch collection fashions and Galaxy smartphones. It’s 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 meant for people beforehand identified with sleep apnea. Customers shouldn’t depend on this function as an alternative choice to skilled analysis or therapy by a professional healthcare supplier. The info supplied by this system can also be not meant to help clinicians in diagnosing sleep issues.
2 Availability could 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. On account of regulatory restrictions in acquiring approval and registration as a Software program as a Medical System (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 could range 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, 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 of a standard but critical medical situation, sleep apnea causes somebody to cease respiration whereas asleep, which can lead to disruptions in oxygen provide, decrease sleep high quality, and different well being problems reminiscent of 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 modifications in SpO₂ ranges associated to apnea and hypopnea patterns and estimates the Apnea-Hypopnea Index to tell customers of potential signs.
