FDA-cleared Belun Sleep System may speed up OSA diagnosis for 1 billion population 

FDA-cleared Belun Sleep System may speed up OSA diagnosis for 1 billion population 

FDA-cleared Belun Sleep System may speed up OSA diagnosis for 1 billion population 

Belun Technology has just received FDA 510(k) clearance (K-document: K222579) 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 OSA1. 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.

“Our new company direction results from the co-created insights after collaborating with worldwide researchers. Sleep takes up so much human time, but we know little about it. Our vision is to keep people healthy with our preventive healthcare data.”

Lydia Leung, CEO of Belun Technology

Worldwide obesity epidemic & the aging population

The sedentary lifestyle of people has led to an increasing prevalence of cardiovascular disease, poor sleep patterns, evaluated stress & obesity. OSA is common in patients with high BMI. Therefore, the worldwide obesity epidemic and the aging population demographic will likely contribute to the rising global prevalence of OSA. According to the World Economic Forum, 1 in 3 adults worldwide will suffer from 2 or more chronic conditions, leading to annual healthcare costs with an 80-300% increment2. World Health Organization estimates a projected 10 million health workers shortfall by 20303. Researchers predicted demand for healthcare workers will increase to 80 million by 2030, but supply will only reach 65 million, creating a healthcare worker deficit of 15 million. The anticipated shortage requires some immediate actions, or access to primary healthcare would be at risk. 

Lancet report1 – Prevalence of OSA in different countries. AHI=apnoea-hypopnoea index

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 AASM4, “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.” 

Belun® Ring is adopted as a digital sleep diary as part of the CBT-I treatment in Hong Kong
Belun® Ring is adopted as a digital sleep diary as part of the
CBT-I treatment in Hong Kong

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 report1.

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 SystemBelun Ring, 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” (https://jcsm.aasm.org/doi/10.5664/jcsm.8592),

2) “Detection of obstructive sleep apnea using Belun Sleep Platform wearable with neural network based algorithm and its combined use with STOP-Bang questionnaire” (https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0258040),

3)Belun® Ring (Belun Sleep System BLS-100): Deep Learning-Facilitated Wearable Enables OSA Detection, Apnea Severity Categorization, and Sleep Stage Classification in Patients Suspected of OSA  (https://journals.lww.com/jhypertension/Abstract/2023/06000/The_Belun_sleep_platform_to_diagnose_obstructive.16.aspx), 

4) Correlation of Pulse Rate Variability(PRV) and Heart Rate Variability(HRV) Metrics During Sleep in Subjects Suspected of OSA (Accepted in SLEEP conference 2023, Abstract ID: 954).

If you would like to know more about how to adopt Belun’s solution in your organization or home use, please feel free to contact us to schedule a meeting by filling out the form below:


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

2. https://www.weforum.org/agenda/2017/12/healthcare-future-multiple-chronic-disease-ncd/

3. https://www.who.int/news/item/02-06-2022-global-strategy-on-human-resources-for-health–workforce-2030

4. https://aasm.org/wp-content/uploads/2022/05/Tech-Committee-Report.pdf