Samsung Electronics announced that the sleep apnea feature in the Samsung Health Monitor application has received De Novo approval from the United States Food and Drug Administration (FDA). The feature, which detects signs of sleep apnea with a compatible Samsung Galaxy Watch and Phone and was approved by the South Korean Ministry of Food and Drug Safety (MFDS) last October, was also approved by the FDA, breaking new ground in this field.
The sleep apnea feature allows users over the age of 22 to detect symptoms of moderate to severe obstructive sleep apnea (OSA) within a two-night monitoring period for those who have not been diagnosed with chronic sleep apnea, a common condition that is often undiagnosed and untreated. To benefit from this feature, users need to track their sleep twice in a ten-day period, each lasting longer than four hours.
Obstructive sleep apnea causes a person to stop breathing while asleep and can often lead to interruptions in oxygen intake, poor sleep quality and daytime fatigue. Untreated sleep apnea can increase the risks of cardiovascular diseases such as hypertension, coronary artery disease, heart failure, cardiac arrhythmia and stroke. According to the National Sleep Foundation, approximately 25 percent of men and 10 percent of women in the United States suffer from obstructive sleep apnea. The new feature, which will be included in the Samsung Health Monitor application, aims to enable more people to proactively detect moderate or severe obstructive sleep apnea symptoms and seek medical help to reduce the possibility of health complications as a result of this detection.
Good health is closely related to good sleep. Sleep helps our bodies and minds recover, while refreshing and empowering us to start the next day ready. The quality of sleep we get at night greatly affects our physical and mental health, relationships, performance and much more. Aware of the fundamental role of sleep on our health, Samsung focuses on three basic elements for better sleep: Learning sleep patterns, creating better habits and creating a sleep-friendly environment.
Samsung is taking the next step with the sleep apnea feature as part of its commitment to providing the best possible sleep tools to improve the sleep health habits of Galaxy users. This feature will be available on Galaxy Watch series watches in the US via the Samsung Health Monitor app in the third quarter.