Samsung’s sleep apnea feature on the Galaxy Watch is the first of its kind to be approved by the US FDA.

Samsung Electronics announced that the sleep apnea feature(1) of the Samsung Health Monitor app(2) has received De Novo Clearance from the US Food and Drug Administration (FDA). This feature, which detects signs of sleep apnea using Samsung Galaxy Watch And cellular telephone compatible, it was the first of its kind to be approved by the FDA after prior approval from the South Korean Ministry of Food and Drug Safety (MFDS)announced last October.

The sleep apnea feature allows users over 22 years of age who have not been diagnosed with sleep apnea to detect signs of moderate to severe obstructive sleep apnea (OSA) over a two-day monitoring period – a common condition and chronic sleep disorder that often goes undiagnosed and is not treated. To use this feature, users only need to track their sleep of more than four hours twice in ten days.

OSA causes a person to stop breathing during sleep and can often lead to impaired oxygen delivery, decreased sleep quality, and daytime fatigue. Untreated sleep apnea can increase the risk of cardiovascular diseases such as hypertension, coronary artery disease, heart failure, cardiac arrhythmias, and stroke. In accordance with National Sleep Foundation (NSF)Approximately 25% of American men and 10% of American women suffer from OSA. A new app feature is expected Samsung Health Monitor helps more people proactively identify moderate or severe OSA and, when detected, seek medical attention to reduce the likelihood of complications associated with it. with health.

Good health is closely related to good sleep as it helps your body and mind recover and allows you to wake up rested and prepared for the day ahead. The quality of sleep you get each night has a significant impact on your physical and mental well-being, relationships, productivity and more. Samsung recognizes the important role sleep plays in our health and well-being, focusing on three key elements to help you sleep better: Learn your sleep patterns, develop better habits, and create an environment conducive to sleep.

With the Sleep Apnea feature, Samsung takes another step in its commitment to offering Galaxy users the best tools to improve their sleep habits. This feature will be available on the Galaxy Watch series in the US through the Samsung Health Monitor app in the third quarter of 2024(3).

(1) Sleep Apnea is an over-the-counter mobile health app that runs on your Samsung Galaxy Watch and compatible phone. This feature is designed to detect signs of moderate to severe obstructive sleep apnea in the form of significant interruptions in breathing in adult users aged 22 years and older over a two-day monitoring period. It is designed 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 as a substitute for traditional diagnosis and treatment by a qualified physician. The data provided by this device is also not intended to assist physicians in diagnosing sleep disorders.

(2) Availability may vary by market or device. Due to market restrictions on obtaining Software as a Medical Device (SaMD) approval/registration, it only works on watches and smartphones purchased in markets where the service is currently available (however, service may be limited when users travel to markets without service). ).

(3) Availability may vary by market, company, model and connected smartphone.