
Samsung Expands Galaxy Watch Sleep Apnea Detection
Samsung has announced a significant expansion of its Galaxy Watch sleep apnea detection feature, bringing the technology to a wider global audience. The feature, previously available in select markets, has now received regulatory approval in 34 European markets, as well as Australia and Singapore. This expansion follows successful regulatory clearances in South Korea and the United States in 2023.
European and Global Rollout
The rollout is facilitated by the feature's recent CE marking in the European Economic Area, signifying compliance with EU health, safety, and environmental standards. Samsung notes that availability may vary slightly across European countries due to regional registration processes. In Australia and Singapore, the feature has gained clearance from the Therapeutic Goods Administration and the Health Sciences Authority respectively.
Device Compatibility and Usage
The sleep apnea detection feature is compatible with Galaxy Watch 4 series devices and newer models running Wear OS 5 or higher. Samsung emphasizes that while the feature can detect potential signs of sleep apnea using the watch's BioActive Sensor, it is not a replacement for a medical diagnosis. Users with existing sleep apnea diagnoses should consult their healthcare provider.
Regulatory Approvals and Timeline
The journey towards global availability began in 2023 with approval from South Korea's Ministry of Food and Drug Safety, followed by FDA clearance in the US. The US rollout included a requirement for users aged 22 and older to consistently wear their Galaxy Watch for at least four hours over a ten-day period to ensure accurate data collection. This strategic expansion highlights Samsung's commitment to integrating advanced health monitoring capabilities into its wearable technology.
Source: Android Central