Can a Smartwatch or Smart Ring Detect Sleep Apnea? What FDA Has Authorized and How Accurate It Is
Samsung and Apple now have FDA-authorized features that flag signs of moderate to severe sleep apnea, and Samsung's 2026 clearance extends to the Galaxy Ring. None of them diagnoses it, and a no-alert result does not rule it out. Here are the numbers from FDA's own documents.
By Kymata Health Editorial Published Last checked
This guide
Sleep Trackers & Smart Rings- Question
- Can a smartwatch or smart ring tell me if I have sleep apnea?
- Sources
- 7 cited
- Quick answers
- 3 questions
- Clinician review
- None; sources cited inline
Key takeaways
5 points- FDA has authorized over-the-counter sleep apnea risk features from Samsung (Galaxy Watch in 2024, Galaxy Watch and Galaxy Ring in 2026) and Apple (Apple Watch, 2024)123.
- They screen for signs of moderate to severe sleep apnea in adults without a diagnosis; none is a diagnosis or replaces a sleep study123.
- Apple's feature caught 66.3% of people with moderate to severe apnea and correctly stayed silent for 98.5% of those without it2.
- On Samsung's 2026 version, the ring caught 77.9% of cases with 95.9% specificity, and the watch 90.8% with 90.3% specificity3.
- Diagnosis still needs polysomnography or a home sleep apnea test, and the AASM recommends against diagnosing apnea from questionnaires or prediction tools alone4.
What FDA has authorized so far
FDA created a device type, an "over-the-counter device to assess risk of sleep apnea," when it granted Samsung's De Novo request on Feb. 6, 20241. These features give a notification of sleep apnea risk to people who have not been diagnosed; they are not meant to provide a standalone diagnosis, replace polysomnography, or act as an apnea monitor2. Searching FDA's device database on Oct. 14, 2026, we found three authorizations of this type, all for watches or rings:
- Samsung Sleep Apnea Feature (Feb. 2024): Galaxy Watch with a Galaxy phone, adults 22 and older. It looks for repeated drops in blood oxygen over two nights within 10 days, on demand1.
- Apple Sleep Apnea Notification Feature (Sept. 2024): Apple Watch with an iPhone, adults 18 and older. It uses the watch's accelerometer to estimate breathing disturbances, checks them in rolling 30-day windows, and notifies you only if it sees a pattern2.
- Samsung Sleep Apnea Feature v2.0 (July 2026): Galaxy Watch or Galaxy Ring with a Galaxy phone, adults 18 and older, using optical (PPG) and motion sensors over two nights3.
How accurate they are, from FDA's documents
Sensitivity is the share of people with moderate to severe apnea (AHI of 15 or more) who got a positive result. Specificity is the share of people without it who were correctly told nothing was found. The companies ran these studies to support their own applications:
- Apple Watch: 1,499 people enrolled and 1,278 were analyzed against a home sleep apnea test. Sensitivity 66.3%, specificity 98.5%, and no false alerts in anyone with a normal AHI2. In plain terms, about one in three people with moderate to severe apnea got no alert.
- Samsung Galaxy Watch (2024): of 620 people enrolled in a sleep-lab study, sensitivity was 82.7% (167 of 202) and specificity 87.7% (235 of 268). It missed its own pre-set specificity target; Samsung's post-hoc analysis found that 23 of the 33 false positives had at least one night of moderate to severe apnea on polysomnography1.
- Samsung v2.0 (2026): on the watch, sensitivity 90.8% and specificity 90.3%; on the Galaxy Ring, sensitivity 77.9% and specificity 95.9%3. On the ring, sensitivity was lower in women (63.2%) than in men (85.5%)3.
What about Oura, RingConn and other rings?
Some rings show blood-oxygen dips or a "breathing disturbance" estimate, and RingConn markets sleep-apnea monitoring. In our Oct. 14, 2026 check, those were not among FDA's authorizations for this device type; the only ring we found was Samsung's Galaxy Ring, under the 2026 clearance3. A wellness score is not a screening result, and neither is a diagnosis. See what sleep rings can and can't measure and our ring comparison.
Why screening matters, and why a quiet watch isn't an all-clear
Obstructive sleep apnea is common and often undiagnosed. A 2019 analysis estimated that 936 million adults aged 30 to 69 worldwide have mild to severe apnea and 425 million moderate to severe, and linked it to neurocognitive and cardiovascular harm; it was funded by ResMed, which sells sleep apnea equipment5.
Apple's labeling is explicit that the absence of a notification does not mean the absence of sleep apnea2, and none of these features is meant to find mild apnea. They are also not for people already diagnosed12.
When to see a clinician, whatever your device says
See a clinician if you get an alert, or if you have warning signs without one: loud snoring, someone seeing you stop breathing or gasp at night, waking unrefreshed, or daytime sleepiness, especially when driving. The AASM recommends polysomnography, or a home sleep apnea test for uncomplicated adults likely to have moderate to severe apnea, and an in-lab study if a home test is negative or inconclusive4. People with significant heart or lung disease, neuromuscular weakness, chronic opioid use, a history of stroke or severe insomnia should have in-lab polysomnography rather than a home test4.
Who should not rely on these features at all: anyone already diagnosed (they are not meant to monitor treatment), people under the labeled age, and anyone using them in place of the test a clinician has ordered123.
Quick answers
Questions
3 answersIs the Apple Watch sleep apnea feature FDA-approved?
It is FDA-cleared through a 510(k) (September 2024) as a notification feature, not a diagnosis2.
Can the Samsung Galaxy Ring detect sleep apnea?
Samsung's Sleep Apnea Feature v2.0 was cleared in July 2026 to run on the Galaxy Ring; in testing the ring caught 77.9% of moderate to severe cases3. Samsung said it would reach the ring in a fall 2026 update without giving a date7, and it was not listed on Samsung's US Galaxy Ring page when we checked on Oct. 14, 20266. It is a risk screen, not a diagnosis.
If my watch never alerts me, am I fine?
Not necessarily. No alert does not rule out sleep apnea, and these features do not look for mild apnea2.
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References
Every study and document cited in this guide, numbered as in the text.
Sources
7 sources- 1De Novo classification request for Sleep Apnea Feature (DEN230041), decision summary. U.S. Food and Drug Administration, 2024.
- 2510(k) K240929: Sleep Apnea Notification Feature (SANF), Apple Inc.. U.S. Food and Drug Administration, 2024.
- 3510(k) K261011: Sleep Apnea Feature (v2.0), Samsung Electronics Co., Ltd.. U.S. Food and Drug Administration, 2026.
- 4Clinical Practice Guideline for Diagnostic Testing for Adult Obstructive Sleep Apnea: An American Academy of Sleep Medicine Clinical Practice Guideline. J Clin Sleep Med, 2017. PMID 28162150
- 5Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med, 2019. PMID 31300334
- 6Galaxy Ring (US product page). Samsung, 2026.
- 7Samsung announces FDA-cleared smart ring for sleep apnea risk. MobiHealthNews, 2026.
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