Sleep apnea detection on Samsung Galaxy Watch gets FDA approval

Our smartwatches and wearables are capable of a lot when it comes to tracking our health. However, in many cases, companies will need approval from regulators before they can deploy or promote certain features. Here in the United States, that regulatory body is usually the Food and Drug Administration (FDA), and today it brought a big victory for Samsung.

Today, Samsung announced that it has received De Novo clearance from the FDA for a sleep apnea detection feature on the Samsung Galaxy Watch. This is notable because it is an industry first: no other consumer smartwatch has this capability, including the Apple Watch, Samsung’s main competitor in this area.

In case you’re curious, “De Novo authorization” is described by the FDA as follows:

The De Novo application provides a commercialization pathway to classify new medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for their intended use, but for which there is no There is no main device legally marketed.

In other words, the FDA is allowing Samsung to market the Galaxy Watch as a sleep apnea detection device because there is “reasonable assurance of safety and effectiveness.”

According to a Samsung Press release In this regard, obstructive sleep apnea (OSA) affects up to 25% of men and 10% of women in the United States. OSA causes a temporary cessation of breathing during sleep, which obviously negatively affects sleep quality and could be dangerous to a person’s overall health. OSA is also linked to cardiovascular diseases such as hypertension, coronary heart disease, heart failure, cardiac arrhythmias and stroke. Being able to detect this and treat it could be incredibly beneficial.

Samsung Galaxy Watch sleep apnea feature: When will we see it?

According to Samsung, you’ll need a Galaxy Watch connected to a Galaxy smartphone for this sleep apnea detection feature to work. The company says it will roll it out in the third quarter of this year.

Unfortunately, Samsung didn’t specify which Galaxy Watch models would benefit from this feature. If we had to guess, the testing would almost certainly have been done on the latest Galaxy Watch 6 and Watch 6 Classic. But we don’t know if they would be the only ones to receive it. Additionally, by the third quarter of this year, we expect the Galaxy Watch 7 series to launch. It is of course possible that testing has been carried out on the first models of this family and the functionality is locked on these watches. At this point we can only speculate.

Samsung has given some information on how this feature works. Users will need to be over 22 and wear their watch to bed for two sleep sessions of at least four hours over a ten-day period. In other words, just track your sleep for two nights a week and you’ll get data on whether or not signs of OSA were detected.