Samsung Electronics announced that the sleep apnea feature1 on the Samsung Health Monitor app2 has received De Novo authorization from the U.S. Food and
Samsung Electronics announced that the sleep apnea feature1 on the Samsung Health Monitor app2 has received De Novo authorization from the U.S. Food and Drug Administration (FDA). This feature, which detects signs of sleep apnea using a compatible Samsung Galaxy Watch and phone, was the first of its kind to be authorized by the FDA following previous approval by Korea’s Ministry of Food and Drug Safety (MFDS), announced last October in Korea.
The sleep apnea feature enables users over the age of 22 who have not been diagnosed with sleep apnea to detect signs of moderate to severe obstructive sleep apnea (OSA) over a two-night monitoring period, a common and chronic sleep condition that often goes undiagnosed and untreated.
