Smart Rings Received FDA Clearance for Sleep Screening

New wearable technology aims to detect sleep apnea cases that have historically gone undiagnosed.

Updated on Sept. 23, 2026 in Sleep Disorders

Bold vector editorial illustration of a sleek smart ring on a textured surface, representing modern home health technology. — Smart rings have received FDA clearance for home sleep apnea screening, offering a new method to detect breathing pauses and address undiagnosed sleep disorders. AI Illustration. Upload story photo >

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Do you trust wearable devices to accurately screen for serious health conditions like sleep apnea?

Manufacturers have introduced FDA-cleared smart rings designed for home sleep apnea screening to address a significant diagnostic gap. These wearable devices monitor physiological data over multiple nights to identify breathing pauses.

Why it matters

Roughly 80 percent of U.S. sleep apnea cases remain undiagnosed, often because symptoms are misattributed to other conditions. Closing this diagnostic gap could help reduce the $149.6 billion in annual health and productivity costs associated with the disorder.

Approximately 90 percent of women with sleep apnea currently go undiagnosed, and post-menopause rates for women reach at least 20 percent. The condition affects 6 percent of women with moderate to severe obstructive sleep apnea.

The players

FDA

The United States Food and Drug Administration is the federal agency responsible for protecting public health by regulating medical devices.

Samsung

Samsung is a multinational technology conglomerate that manufactures electronics and developed the Galaxy Ring wearable.

The details

Devices like the Happy Ring and the Samsung Galaxy Ring allow users to collect sleep data over several nights rather than relying on a single lab test. This method helps capture physiological variability and addresses the tendency for women to be misdiagnosed or overlooked in traditional screening environments.

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 for the Galaxy Ring in 2026.

Health Landscape

The rise of FDA-cleared home wearable technology marks a departure from the historical reliance on single-night in-lab polysomnography for diagnosing sleep apnea. This shift suggests a move toward continuous monitoring to better reflect natural sleeping conditions.

Individuals can now utilize home-based screenings that require wearing a device for multiple nights, potentially avoiding the need for overnight clinical sleep labs. Patients should consult their doctors to determine if these wearable devices are appropriate based on their personal health symptoms.

The takeaway

Home screening devices offer a convenient alternative to traditional testing for those previously unaware of their sleep apnea. Consistent use of these wearables may provide users and their physicians with more accurate long-term physiological data.