Belun Technology announced it received FDA 510(k) clearance for its Belun Sleep System on Feb. 28, 2023. The Belun Sleep System comprises a wearable ring and proprietary deep-learning algorithms that aid in evaluating moderate to severe sleep-related breathing disorders in adult patients with suspected obstructive sleep apnea (OSA).
About the Belun Sleep System
The Belun Sleep System is FDA cleared for in-home sleep apnea tests. The Belun Ring is a cableless photoplethysmography (PPG)-based wearable that is worn on the index finger while sleeping. It records patients’ oxygen saturation, pulse rate, and actigraphy for up to 10 hours per night. Using AI algorithms, the Belun Sleep System also estimates the apnea hypopnea index and categorizes sleep stages.
The AI-enabled wearable ring enables multi-night analyses without the need for in-lab polysomnography. It is prescribed by health care professionals.
About obstructive sleep apnea
OSA is a prevalent and serious sleep disorder where the airway becomes repeatedly blocked during sleep, leading to paused breathing and oxygen deprivation. Commonly caused by the collapse of throat tissues, it can result in loud snoring, choking noises and frequent awakenings, potentially contributing to health issues such as high blood pressure, heart disease, stroke, diabetes and depression.
Read more industry news from the AASM.
