Hong Kong-based Belun Technology received US Food and Drug Administration (FDA) 501(k) clearance for its next-generation Belun Sleep System, a photoplethysmography-based wearable ring to detect obstructive sleep apnea (OSA). 

According to a press release by Belun, the sleep system could potentially speed up OSA diagnosis for nearly 1 billion people worldwide. Belun received FDA clearance for its first-generation ring in 2018.

“We hope to facilitate home sleep tests for identifying undiagnosed OSA. Research shows sleep health is critical for the overall immune system and treatment effectiveness of chronic diseases,” says Belun CEO Lydia Leung, PhD, in a press release. 

The company says it is expanding its focus beyond sleep health and venturing into preventive healthcare, a direction that is a result of collaborating with specialists, according to Belun in the release. Since the launch of the company’s first ring, it has been gradually used in different long-term disease research studies, including those related to stroke, hypertension, insomnia, and dementia.

“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,” says Leung in a press release. “Belun will offer a superb, convenient option that may bring disruption to the sleep health market and encourage suspected patients to take action and kick start their treatment journey.” 

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 the OSA and insomnia markets. For the Indian market, Belun will collaborate with neurologists and sleep specialists “to tap into the millions of untreated” cases of OSA, according to the company press release. 

Photo caption: User wears Belun Ring for home sleep test during sleep.

Photo credit: Belun Technology