 "Samsung gets FDA clearance in US for sleep apnea detection on Galaxy Watch")
Samsung has announced that the sleep apnea feature on the Samsung Health Monitor app has received De Novo authorization from the US Food and Drug Administration (FDA). This feature detects the signs of sleep apnea by monitoring blood oxygen levels of the user during sleep through supported Galaxy Watches. The feature will be available in the US through the Samsung Health Monitor app in the third quarter of 2024.
Last year, Samsung received the approval by South Korea’s Ministry of Food and Drug Safety (MFDS) for the same feature.
The sleep apnea detection feature allows users of age 22 or above to detect the signs of moderate to severe obstructive sleep apnea (OSA) over a two-night monitoring period. Users will be required to track their sleep with the Galaxy Watch twice for more than four hours within a period of ten days. The Galaxy Watch will monitor the blood oxygen level of the user throughout the night to detect any drop in oxygen levels, which is a common symptom of sleep apnea.
Obstructive sleep apnea can cause a person to stop breathing while sleeping that can often result in disruptions in oxygen supply. This results in decreased sleep quality and increased daytime fatigue.
Earlier, Bloomberg’s Mark Gurman reported that Apple is planning to add sleep apnea detection feature alongside blood pressure monitoring on the Apple Watch Series 10, which is expected to launch in September.
Blood Pressure monitoring and electrocardiogram (ECG) monitoring features are already available on the Samsung Galaxy Watch series 4 or later. Last month, Samsung announced that its blood pressure and ECG tracking features have received regulatory clearances and certifications from India’s Central Drugs Standard Control Organization. The features are available in India through the Samsung Health Monitor app.