FDA approves sleep apnea detection feature for Galaxy Watch, an industry first

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 regulatory bodies before they can roll out or promote certain features. Here in the United States, that regulatory body is usually the Food and Drug Administration (FDA), and today, it issued a big win for Samsung.

Today, Samsung announced it has obtained De Novo authorization from the FDA for a sleep apnea detection feature on the Samsung Galaxy Watch. This is notable because it’s an industry first — no other consumer smartwatch has this ability, including the Apple Watch, Samsung’s main competitor in this space.

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

The De Novo request provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.

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 on the matter, obstructive sleep apnea (OSA) affects up to 25% of men and 10% of women in the United States. OSA causes a person to temporarily stop 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 artery disease, heart failure, cardiac arrhythmias, and stroke. Being able to detect this and then 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 linked with a Galaxy smartphone for this sleep apnea detection feature to work. The company says it will roll this out in the third quarter of this year.

Unfortunately, Samsung wasn’t clear on which Galaxy Watch models would get this. If we had to guess, testing for this would almost certainly have been done on the most recent Galaxy Watch 6 and Watch 6 Classic. But we don’t know if they would be the only ones to receive it. Also, by the third quarter of this year, we expect the Galaxy Watch 7 series to launch. It is, of course, possible that testing was conducted on early models of that family, and the feature will be locked to those watches. At this point, we can only speculate.

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