Smart Rings Received FDA Clearance for Sleep Apnea
New FDA-cleared wearable devices now offer a way to screen for sleep apnea at home.
Updated on Sept. 23, 2026 in Sleep Disorders
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Manufacturers have introduced FDA-cleared smart rings designed to screen for obstructive sleep apnea at home. These devices aim to address the significant diagnosis gap for a condition that affects millions of Americans.
Why it matters
Roughly 80 percent of U.S. sleep apnea cases remain undiagnosed, contributing to $149.6 billion in annual health and productivity costs. Improving access to screening is critical because women, in particular, are frequently undiagnosed due to symptoms being misattributed to other conditions.
The FDA has granted clearance to multiple smart rings as Class II medical devices for sleep apnea screening. These devices monitor physiological variability over multiple nights, capturing data patterns that can be missed during a single, one-night laboratory test.
The players
FDA
The federal agency responsible for regulating medical devices and ensuring public health safety.
Samsung
A technology company that manufactures consumer electronics and health-tracking wearables.
The details
These wearables detect breathing pauses by monitoring physiological variability overnight. For instance, the Happy Ring uses an overnight test synced with the Happy Sleep virtual platform, while the Samsung Galaxy Ring requires users to wear the device for two nights within a 10-day window to estimate breathing disruptions.
Timeline
The FDA cleared the Belun Ring in 2023.
The FDA cleared the Happy Ring as a Class II medical device in 2025.
Samsung released a sleep apnea detection feature on the Galaxy Ring in 2026.
Health Landscape
The current standard of care relies heavily on single-night, in-lab studies that often fail to capture the full picture of a patient's breathing patterns. The introduction of home-based smart ring screening marks a shift toward longitudinal monitoring that aims to replace the traditional in-lab polysomnography diagnosis protocol.
If you suspect you have sleep apnea, especially if you are a post-menopausal woman who is among the 20 percent at risk, discuss home-screening options with your doctor. These devices are tools for initial screening and do not replace the need for professional clinical evaluation and treatment planning.
The takeaway
Closing the diagnosis gap is essential, as undiagnosed sleep apnea is associated with high health and productivity costs. If you experience daytime fatigue or are told you snore, ask your primary care physician whether a home-screening device is an appropriate starting point for your health care.
Further reading
Learn more about the latest innovations in home diagnostics in our Sleep Disorders section.
Source note: This article includes information reported by Us Weekly.
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