Belun Sleep Ring with AI Now FDA Cleared

belun sleep ring fda cleared

Belun Technology has just received FDA 510(k) clearance from the US Food and Drug Administration (FDA) for its Belun Sleep System as the world’s first wearable ring for obstructive sleep apnea (OSA) using AI. Belun Sleep Platform, which is comfortable and easy to use, is believed to speed up the diagnosis of 936 million worldwide with moderate to severe OSA.1 It may result in massive savings on medical expenditures for chronic disease management of the aging population.

Keep people healthy with our preventive healthcare data

Belun’s CEO, Dr. Lydia Leung, shared: “we hope to facilitate home sleep tests for identifying undiagnosed OSA. Research shows sleep health is critical for the overall immune system & treatment effectiveness of chronic diseases.” The company is expanding towards preventive healthcare from the original sleep health. The new direction is an insight found from collaborating with worldwide specialists. Since the launch of our 1st generation Belun Ring in 2018, it has been gradually adopted in other research on long-term diseases, including stroke, hypertension, insomnia, dementia, etc.

PPG-based wearable with medical accuracy

Belun’s CEO, Lydia Leung, shared: “Belun® Ring is a user and environmentally friendly PPG-based wearable with medical accuracy. Belun will offer a superb convenient option that may bring disruption to the sleep health market & encourage suspected patients to take action and kick start their treatment journey.” According to AASM, “ubiquitous availability of PPG technology may allow for OSA diagnosis at scale.” There is “an increased interest in new technologies with therapeutic potential.”

Chronic Disease Management via AI Preventive Healthcare

Belun’s vision is to help people better manage their chronic diseases through artificial intelligence and big data analytics to alleviate medical expenditures due to the aging population. Our solution allows caregivers and patients to follow their treatment effectiveness, select personalized solutions, and enhance treatment compliance. Lydia further shared: “Long-term monitoring using medical-grade wearables can help people to identify abnormalities earlier to achieve preventive healthcare.”

Worldwide partnership for the OSA markets

To cope with the massive market, Belun has teamed up with global partners to customize solutions for local communities in different countries. Some sleep lab groups in the United States will launch the Belun Sleep System to cater to both the OSA & insomnia markets. For the Indian market, Belun will collaborate with renowned neurologists & sleep specialists to tap into the millions of untreated OSA. The two markets have 104 million suspected OSA, according to the Lancet report.1

Partnering with Belun

Up to now, over a hundred organizations, including HK hospital authority hospitals, medical groups, clinic groups, dentists, and elderly centers selected to use the Belun Sleep System, Belun® Ring and Sleep App, and Belun® remoVital monitoring system. Many doctors read our medical journal papers, including 1) “Belun® Ring Platform: a novel home sleep apnea testing system for assessment of obstructive sleep apnea” ( and 2) “Detection of obstructive sleep apnea using Belun Sleep Platform wearable with neural network based algorithm and its combined use with STOP-Bang questionnaire” (


1.A.V, Benjafield et al, Lancet Respiratory Medicine, 2019; 2. Susanna Ng et al, PLOS One, 2015

Source: Belun Technology

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