Samsung Electronics introduced as we speak that the Sleep Apnea characteristic1 on the Galaxy Watch sequence — obtainable 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 characteristic’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 expertise. Moreover, the characteristic 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 variety for a wearable system to detect indicators of average to extreme obstructive sleep apnea.5 The Sleep Apnea characteristic 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 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 characteristic, extra customers can now detect signs6 earlier — serving to to forestall well being points related to this widespread but typically undiagnosed situation.
The Sleep Apnea characteristic displays Samsung’s ongoing dedication to offering customers with significant insights to help wholesome sleep habits. By increasing entry to this FDA-authorized characteristic globally, Samsung is empowering customers worldwide to take proactive steps towards higher sleep well being.
1 The Sleep Apnea characteristic is an over-the-counter (OTC), software-only cell medical utility working on appropriate Galaxy Watch sequence fashions and Galaxy smartphones. It’s supposed to detect indicators of average to extreme obstructive sleep apnea within the type of vital respiration disruptions in grownup customers age 22 and older over a two-night monitoring interval. The characteristic is designed for on-demand use and isn’t supposed for people beforehand identified with sleep apnea. Customers shouldn’t depend on this characteristic as an alternative to skilled prognosis or remedy by a certified healthcare supplier. The information offered by this system can be not supposed to help clinicians in diagnosing sleep issues.
2 Availability could differ by market, service, mannequin or paired smartphone. The characteristic is accessible on Galaxy Watch4 sequence and later fashions operating Put on OS 5.0 or later and have to be paired with a Galaxy smartphone operating Android 12.0 or later. Resulting from regulatory restrictions in acquiring approval and registration as a Software program as a Medical Gadget (SaMD), the characteristic solely works on supported Galaxy Watch series models and Galaxy smartphones bought in markets the place the service is presently obtainable. Service could also be restricted when customers journey to unsupported markets.
3 Availability could differ 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 of a standard but critical medical situation, sleep apnea causes somebody to cease respiration 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 characteristic 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.
