Samsung Electronics introduced that the sleep apnea characteristic1 on the Samsung Well being Monitor app2 has obtained De Novo authorization from the U.S. Meals and Drug Administration (FDA). This characteristic, which detects indicators of sleep apnea utilizing a appropriate Samsung Galaxy Watch and telephone, was the primary of its type to be licensed by the FDA following previous approval by Korea’s Ministry of Food and Drug Safety (MFDS), introduced final October in Korea.


The sleep apnea characteristic allows customers over the age of twenty-two who haven’t been identified with sleep apnea to detect indicators of average to extreme obstructive sleep apnea (OSA) over a two-night monitoring interval, a standard and persistent sleep situation that always goes undiagnosed and untreated. To make the most of the characteristic, 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 danger of cardiovascular illnesses resembling hypertension, coronary artery illness, coronary heart failure, cardiac arrhythmia and stroke. In keeping with the National Sleep Foundation (NSF), roughly 25% of males and 10% of ladies within the U.S. expertise OSA. The brand new characteristic on the Samsung Well being Monitor app is anticipated to assist extra folks proactively detect average or extreme types of OSA, and on account of the detection search medical care to scale back the potential of health-related problems.


Good well being is strongly linked to good sleep. Sleep helps our bodies and minds get better and empowers folks to get up refreshed and prepared for the day forward. The standard of sleep folks get each night time has a major influence on their bodily and psychological well-being, relationships, efficiency and extra. Samsung acknowledges the foundational function 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 atmosphere.


With the sleep apnea characteristic, 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 characteristic shall be obtainable on the Galaxy Watch sequence within the U.S. through the Samsung Well being Monitor app within the third quarter.3



1 The Sleep Apnea Characteristic is an over-the-counter (OTC) software-only, cellular medical software working on a appropriate Samsung Galaxy Watch and telephone. This characteristic is meant to detect indicators of average to extreme obstructive sleep apnea within the type of important respiration disruptions in grownup customers 22 years and older, over a two-night monitoring interval. It’s supposed for on-demand use. This characteristic will not be supposed for customers who’ve beforehand been identified with sleep apnea. Customers mustn’t use this characteristic to switch conventional strategies of analysis and remedy by a professional clinician. The information offered by this machine can also be not supposed to help clinicians in diagnosing sleep problems.
2 Availability might range by market or machine. Resulting from market restrictions in acquiring approval/registration as a Software program as a Medical System (SaMD), it solely works on watches and telephones bought within the markets the place service is at present obtainable (nonetheless, service could also be restricted when customers journey to non-service markets).
3 Availability might range by market, provider, mannequin, or paired telephone.