Samsung Health Monitor app has received De Novo authorization from the United States Food and Drug Administration (FDA) for its sleep apnea feature. This marks the first time that a sleep apnea feature has been authorized by FDA following previous approval by South Korea’s Ministry of Food and Drug Safety (MFDS).
The sleep apnea feature on the Samsung Health Monitor app 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. To utilize this feature, users simply need to track their sleep twice for more than four hours within a ten-day period using their compatible Samsung Galaxy Watch and Phone.
Obstructive Sleep Apnea (OSA) is a common and chronic sleep condition that often goes undiagnosed and untreated, despite affecting roughly 25% of men and 10% of women in the U.S. It causes a person to stop breathing while sleeping and can result in disruptions in oxygen supply, lower sleep quality, and daytime fatigue. Untreated OSA can compound the risk of cardiovascular diseases such as hypertension, coronary artery disease, heart failure, cardiac arrhythmias, and stroke.
The new feature on the Samsung Health Monitor app is expected to help more people proactively detect moderate or severe forms of OSA, enabling them to seek medical care to reduce the possibility of health-related complications. By focusing on three key elements for better sleep – understanding sleep patterns, building better habits, creating a sleep-friendly environment – Samsung recognizes the foundational role that good quality sleep plays in our overall health and well-being.