Legal Certification Acquired Before EU Market Launch
Mobile Medical App... Recognizes Abnormal Sleep Health
Now Available in a Total of 70 Markets
Samsung Electronics announced on June 6 that its 'Sleep Apnea Detection' feature, developed using the Galaxy Watch series, has received CE certification in Europe.
CE, which stands for European Conformity, is a certification indicating that a product meets the essential requirements related to health, safety, environmental protection, and consumer protection in the European Union (EU). The CE mark is a legal requirement that must be obtained before products where safety is critical?such as medical devices, electronic products, machinery, and toys?can be released on the EU market.
Sleep apnea is a condition in which breathing temporarily stops during sleep, which impedes the supply of oxygen in the blood, lowers sleep quality, and causes fatigue. If left untreated, it can increase the risk of cardiovascular diseases such as hypertension, heart failure, arrhythmia, and stroke, and may lead to complications.
The sleep apnea detection feature is an over-the-counter (OTC) mobile medical application based on software that operates on Samsung Galaxy Watch and compatible smartphones. It helps users quickly recognize and respond to abnormal sleep health by detecting signs of sleep apnea at an early stage.
This feature uses the 'BioActive Sensor' of the Galaxy Watch to measure blood oxygen saturation (SpO2) during sleep. It analyzes patterns in the measured oxygen saturation values that indicate apnea or hypopnea, calculates an estimated Apnea-Hypopnea Index (AHI) during sleep, and notifies the user about the presence of symptoms.
The sleep apnea detection feature is intended for adult users aged 22 and older. It detects signs of moderate to severe obstructive sleep apnea by measuring sleep data from two nights, each with at least four hours of sleep, within a ten-day period.
With this CE certification, the sleep apnea detection feature is now approved not only in 34 regions across Europe but also in countries such as Australia and Canada. As a result, it will be available in a total of 70 markets, helping users detect related symptoms at an early stage.
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