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

Samsung Electronics introduced that the sleep apnea function¹ on the Samsung Well being Monitor app² has obtained De Novo authorization from the U.S. Meals and Drug Administration (FDA). This function, which detects indicators of sleep apnea utilizing a suitable Samsung Galaxy Watch and telephone, was the primary of its type to be approved by the FDA following previous approval by Korea’s Ministry of Food and Drug Safety (MFDS), introduced final October in Korea.

The sleep apnea function allows customers over the age of twenty-two who haven’t been recognized with sleep apnea to detect indicators of reasonable to extreme obstructive sleep apnea (OSA) over a two-night monitoring interval, a typical and continual sleep situation that always goes undiagnosed and untreated. To make the most of the function, customers can merely observe their sleep twice for greater than 4 hours inside a ten-day interval.

OSA causes an individual to cease respiration whereas sleeping and may typically lead to disruptions in oxygen provide, decreased sleep high quality and elevated daytime fatigue. Untreated sleep apnea can compound the chance of cardiovascular illnesses comparable to hypertension, coronary artery illness, coronary heart failure, cardiac arrhythmia and stroke. In accordance with the National Sleep Foundation (NSF), roughly 25% of males and 10% of girls within the U.S. expertise OSA. The brand new function on the Samsung Well being Monitor app is predicted to assist extra folks proactively detect reasonable or extreme types of OSA, and because of the detection search medical care to scale back the opportunity of health-related problems.

Good well being is strongly linked to good sleep. Sleep helps our bodies and minds get well and empowers folks to get up refreshed and prepared for the day forward. The standard of sleep folks get each night time has a big affect on their bodily and psychological well-being, relationships, efficiency and extra. Samsung acknowledges the foundational position that sleep serves in folks’s well being and well-being by specializing in three key elements for better sleep: understanding sleep patterns, constructing higher habits and making a sleep-friendly surroundings.

With the sleep apnea function, Samsung is taking the subsequent step in its ongoing dedication to offer Galaxy customers with the absolute best sleep instruments to enhance their sleep well being habits. The function might be obtainable on the Galaxy Watch sequence within the U.S. by way of the Samsung Well being Monitor app within the third quarter.³

¹ The Sleep Apnea Function is an over-the-counter (OTC) software-only, cell medical utility working on a suitable Samsung Galaxy Watch and telephone. This function is meant to detect indicators of reasonable to extreme obstructive sleep apnea within the type of vital respiration disruptions in grownup customers 22 years and older, over a two-night monitoring interval. It’s supposed for on-demand use. This function is just not supposed for customers who’ve beforehand been recognized with sleep apnea. Customers mustn’t use this function to interchange conventional strategies of prognosis and therapy by a professional clinician. The information supplied by this gadget can be not supposed to help clinicians in diagnosing sleep problems.
² Availability might differ by market or gadget. Attributable to market restrictions in acquiring approval/registration as a Software program as a Medical Gadget (SaMD), it solely works on watches and telephones bought within the markets the place service is at the moment obtainable (nonetheless, service could also be restricted when customers journey to non-service markets).
³ Availability might differ by market, provider, mannequin, or paired telephone.