Belun receives FDA clearance for sleep system
By HME News Staff
Updated 12:56 PM CDT, Wed March 15, 2023
HONG KONG - Belun Technology has received U.S. Food and Drug Administration 501(k) clearance for its next-generation Belun Sleep System, a photoplethysmography-based wearable ring to detect obstructive sleep apnea. Belun received FDA clearance for its first-generation ring in 2018. “We hope to facilitate home sleep tests for identifying undiagnosed OSA,” says Belun CEO Lydia Leung, PhD. “Research shows sleep health is critical for the overall immune system and treatment effectiveness of chronic diseases.” Belun is developing a sleep health index based on its medical-grade wearable, AI and big data analytics to enhance public awareness and understanding of sleep. Users can learn, for example, how their sleep quality will be affected by their daily habits like exercise and their environment (e.g. air pollution index and medication). Belun has teamed with global partners to customize solutions for local communities in different countries, including sleep labs in the United States.
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