RIDGEFIELD PARK, New Jersey—Samsung Electronics Co., Ltd. announced that the sleep apnea feature1 on the Samsung Health Monitor app2 has received De Novo authorization from the United States Food and Drug Administration (FDA). This feature, which will detect signs of sleep apnea using a compatible Samsung Galaxy watch and phone, is the first of its kind to be authorized by FDA following previous approval by South Korea’s Ministry of Food and Drug Safety (MFDS), announced last October in South Korea.
The sleep apnea feature will enable 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. To utilize the feature, users will be able to simply track their sleep twice for more than four hours within a ten-day period.
OSA causes a person to stop breathing while sleeping and can often result in disruptions in oxygen supply, lower sleep quality and daytime fatigue. Untreated sleep apnea can compound the risk of cardiovascular diseases such as hypertension, coronary artery disease, heart failure, cardiac arrhythmias and stroke. According to the National Sleep Foundation (NSF), roughly 25% of men and 10% of women in the U.S. experience OSA. The new feature on the Samsung Health Monitor app is expected to help more people proactively detect moderate or severe forms of OSA, and as a result of the detection seek medical care to reduce the possibility of health-related complications.
