Samsung’s Sleep Apnea Feature on Galaxy Watch First of Its Kind Authorized by US FDA

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. To utilize the feature, users can 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, decreased sleep quality and increased daytime fatigue. Untreated sleep apnea can compound the risk of cardiovascular diseases such as hypertension, coronary artery disease, heart failure, cardiac arrhythmia 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.

Good health is strongly linked to good sleep. Sleep helps bodies and minds recover and empowers people to wake up refreshed and ready for the day ahead. The quality of sleep people get every night has a significant impact on their physical and mental well-being, relationships, performance and more. Samsung recognizes the foundational role that sleep serves in people’s health and well-being by focusing on three key elements for better sleep: understanding sleep patterns, building better habits and creating a sleep-friendly environment.

With the sleep apnea feature, Samsung is taking the next step in its ongoing commitment to provide Galaxy users with the best possible sleep tools to improve their sleep health habits. The feature will be available on the Galaxy Watch series in the U.S. via the Samsung Health Monitor app in the third quarter.³

¹ The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and phone. This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two-night monitoring period. It is intended for on-demand use. This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this device is also not intended to assist clinicians in diagnosing sleep disorders.
² Availability may vary by market or device. Due to market restrictions in obtaining approval/registration as a Software as a Medical Device (SaMD), it only works on watches and phones purchased in the markets where service is currently available (however, service may be restricted when users travel to non-service markets).
³ Availability may vary by market, carrier, model, or paired phone.