Samsung obtains FDA DeNovo for Sleep Apnea detection prior to the release of Galaxy Ring

Samsung Galaxy Ring Sleep Apnea

Samsung Electronics has received the FDA’s DeNovo approval this week for its upcoming Sleep Apnea future. This could be the new and unique feature that will arrive with the Samsung Galaxy Ring, when it is released later this year.

The new FDA approval means that we could be seeing Sleep Apnea monitoring future soon in the Samsung watches and the newly released Smart Ring.

Samsung Galaxy Sleep Apnea monitoring FDA approval

While smartwatches and rings can’t collect all the same health information as an official sleep apnea test, there is some overlap in their capabilities. These areas include:

  • Sleep Patterns and Quality
  • Cardiovascular Activity
  • AirFlow into the lungs
  • Oxygen Levels in Your Blood
  • Body Positioning During Sleep
  • Effort Needed to Breathe

In the case of Sleep Apnea monitoring, chances are that the monitoring uses the key blood oxygen monitoring (SpO2) along with motion detection to detect if you are a side sleeper and such.

We think that this feature is going to be a part of the Samsung Galaxy Ring release. Samsung’s general approach to health tracking comes down to four areas of focus: activity, nutrition, sleep and stress. 

Sleep Apnea Monitoring and Wearables

Other wearable players have also been engaged in the area of advanced sleep monitoring and analysis.

Folks at Withings have been trying to get the FDA approval for Sleep Apnea for their ScanWatch for years and it appears that Samsung may be the first wearable device maker to get the FDA stamp of approval.

Withings Sleep Analyzers accurately detect moderate-severe sleep apnea syndrome in patients suspected of sleep apnea syndrome. This simple and automated approach could be of great clinical value given the high prevalence of sleep apnea syndrome in the general population. This was noted during the research of the ‘under the mattress’ Withings sleep analyzer device.

Some Garmin users noted last year that the company released a Sleep Pulse Ox widget last year in the Garmin Connect app. Although this led to speculation that Garmin may be positioning for Sleep Apnea monitoring, we haven’t seen a FDA approval of Garmin’s Sleep apnea monitoring feature.

Apple’s next series of watches are rumored to have some of the advanced sleep monitoring features along with potential sleep apnea monitoring features. This could however get delayed till we find some resolution around the Apple Vs Massimo case, since the apnea detection feature leverages the SpO2 feature.

The other key player in the area of Sleep apnea monitoring is Oura Ring. While the Oura Ring cannot be used to diagnose sleep apnea, it can provide helpful insights on the quality of your sleep. Individuals with sleep apnea may experience reduced deep and REM sleep, which may be reported as excessive awake time in the Oura App. 


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