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MagyarSamsung Galaxy Watch's new sleep apnea tool gets FDA approval
A new sleep apnea feature for the Samsung Galaxy Watch has been approved by the US Food and Drug Administration (FDA). According to a press release from the company, the wearable has received De Novo authorization, meaning the agency believes that there is a "reasonable assurance of safety and effectiveness for the intended use".
The feature is the first of its kind to be approved by the FDA and has already been given the green light in Korea by the Ministry of Food and Drug Safety (MFDS). The tool enables users over the age of 22 with a Galaxy smartwatch to detect signs of moderate to severe obstructive sleep apnea (OSA). Samsung suggests that symptoms often go undetected and can cause poor sleep quality and, in some cases, increase the risk of some cardiovascular diseases.
The tool requires two nights of sleep, which the company defines as two rest periods lasting for four or more hours within a ten-day window. Positive results will appear in a notification via the Samsung Health Monitor app, which is available for iOS and Android. The app will advise you to seek medical attention if your watch detects signs. Samsung's sleep apnea detection tool will be available in the US via the Samsung Health Monitor app in Q3. It remains to be seen when the feature could roll out to more regions like Europe.
