Samsung scores FDA de novo nod for sleep apnea feature on Galaxy smartwatches

Amid rumors that Apple is in the process of adding a sleep apnea detection feature to its namesake wearables, Samsung has beat it to the punch.

The Korean electronics giant announced over the weekend that the FDA had handed down a de novo clearance for its own smartwatch-based sleep apnea feature, which it said marked the regulator’s first such authorization.

The feature was cleared in Korea last fall and was slated to begin its rollout in the country early this year; with FDA clearance now in hand, too, Samsung said Galaxy Watch users in the U.S. will be able to access the tool starting in the third quarter of this year.

The sleep apnea detection feature is housed alongside Samsung’s other medical monitoring tools within the Samsung Health Monitor app, which is added to Galaxy smartwatches and compatible smartphones.

The feature is meant to be used on demand, rather than running automatically in the background. When it’s activated, it’ll flag any potential signs of moderate to severe obstructive sleep apnea if a user wears their Galaxy smartwatch to track at least four hours of sleep twice within a 10-day span.

Samsung’s technology is indicated for use by people who are at least 22 years old and haven’t been diagnosed with obstructive sleep apnea. The company has framed the feature as a guide that could lead Galaxy Watch wearers to speak further with their doctors about a possible OSA diagnosis, noting in the fine print of Saturday’s announcement that the app itself shouldn’t be used as a diagnostic tool and that “the data provided by this device is also not intended to assist clinicians in diagnosing sleep disorders.”

Even so, if the feature helps to encourage users to consult with a doctor about their sleep health, Samsung suggested that it could help reduce the complications associated with an untreated, worsening condition, such as hypertension, coronary artery disease, heart failure, cardiac arrhythmia and stroke.

Samsung’s de novo nod arrives not long after Bloomberg reported in November that Apple is planning to add its own sleep apnea detection feature to Apple Watches in 2024, though the tech giant itself has yet to confirm those plans.

That report also suggested that Apple will soon be adding high blood pressure notifications to the smartwatch, too—another feature that’s already available on Samsung’s wearables, in the form of on-the-spot blood pressure measurements, though the tool requires regular recalibration and has yet to receive FDA clearance for U.S. use.

Meanwhile, both Samsung and Apple are exploring the possibility of adding noninvasive glucose monitoring to their respective smartwatches. While Apple has yet to publicly provide any updates on that long-reported development process, the head of Samsung Electronics’ digital health team, Hon Pak, M.D., spoke openly about the goal in an interview with Bloomberg last month, saying that Samsung is hoping to add glucose tracking to its growing family of wearables within the next five years.