The Belun Sleep System received U.S. FDA-510(k) clearance as the first AI-enabled medical-grade wearable ring for sleep apnea diagnosis with sleep stages. It has been clinically validated in accredited sleep labs to provide accurate AHI, sleep stages, and autonomic nervous system response, enhancing sleep health management in both HSAT & remote patient monitoring with its multi-night testing & reusable capability.
Medical-grade sleep stages generate positive feedback from medical professionals
Belun Ring, would help physicians & sleep specialists understand the patients’ sleep stages better, differentiate OSA, insomnia, and COMSA (OSA x Insomnia), and thus empower the medical professionals for a more personalized treatment plan. A recap of media highlights about Belun Sleep System achieving FDA clearance is listed below.
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 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:
References
- https://rtmagazine.com/products-treatment/diagnostics-testing/diagnostics/beluns-home-sleep-apnea-testing-device-fda-cleared/
- https://rtsleepworld.com/2023/03/07/belun-sleep-ring-now-fda-cleared/
- https://sleepreviewmag.com/practice-management/laws-regulations/fda/fda-clears-belun-ring/