Samsung expands Galaxy Watch's CE-marked sleep apnea feature internationally

General news News Tech Tech News 06/10/2025

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TECH NEWS – Samsung announced that it is expanding the Sleep Apnea feature available in the Samsung Health Monitor app for the Galaxy Watch series to 70 markets worldwide, including Hungary.

The expansion was facilitated by the acquisition of the European Economic Area (EEA) CE Mark (Conformité Européenne, European Conformity). The CE Mark certifies that Samsung has met the European Union’s strict health, safety and environmental regulations, reinforcing its leading position in sleep technology. The feature was also recently approved by Australia’s Therapeutic Goods Administration (TGA) and Singapore’s Health Sciences Authority (HSA).

The recognition is a milestone, following Samsung’s pioneering De Novo Clearance from the United States Food and Drug Administration (FDA). The company has received the first-of-its-kind clearance for a wearable device that can detect moderate to severe obstructive sleep apnea symptoms. In addition, the sleep apnea feature has been approved by the Korean Ministry of Food and Drug Safety (MFDS), the Brazilian Healthcare Regulatory Agency (ANVISA) and Canadian regulatory authority Health Canada have approved it.

Recognizing the key role sleep plays in overall health, Samsung is committed to improving the quality of sleep for its users by analyzing sleep patterns, providing personalized sleep coaching, and optimizing the sleep environment. The Galaxy Watch’s sleep apnea feature now allows even more users to detect potential symptoms early, helping to prevent health problems related to this common but underdiagnosed condition.

Even the smallest changes in health can make a big difference, starting with a restful night’s sleep, as the quality of sleep can have a significant impact on our physical and mental well-being. Samsung continues to work with the sleep apnea feature is committed to providing Galaxy users with the most effective tools to develop healthy sleep habits. The company is enabling users to take steps forward towards healthier sleep by expanding the sleep apnea feature internationally.

Source: Press release

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