Belun Sleep System BLS-100

by Belun Technology Company Limited  · Based in Hong Kong → — Shed light on your sleep
Neurology Pulmonology Sleep Medicine
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Starts at $299.00 usd for hardware plus $85/month/device for ai-scoring subscription.
Regulatory Status Disclosed

Overview

The Belun Sleep System BLS-100 is an FDA 510(k) cleared AI-powered medical device designed for in-home sleep apnea testing and comprehensive sleep analysis. It comprises the Belun Ring (BLR-100X), a comfortable, cableless wearable worn on the index finger, and proprietary deep-learning algorithms for data analysis.

The system records photoplethysmography (PPG) signals, oxygen saturation (SpO2), pulse rate (PR), heart rate variability (HRV), and actigraphy. Its advanced AI algorithms provide clinically validated sleep stages (Wake, NREM, REM) and estimate the Apnea-Hypopnea Index (AHI), including REM AHI and NREM AHI, which are crucial for understanding OSA phenotypes.

The Belun Sleep System facilitates multiple-night analyses, offering greater accuracy by minimizing the first-night effect and averaging night-to-night variability, a significant advantage over traditional in-lab polysomnography. It aims to speed up the diagnosis of obstructive sleep apnea (OSA) and assist healthcare professionals in personalizing treatment options and evaluating their efficacy.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • FDA 510(k) cleared for in-home sleep apnea tests
  • AI-powered deep learning algorithms for analysis
  • Provides complete sleep architecture (Wake, NREM, REM sleep stages)
  • Estimates Apnea-Hypopnea Index (AHI), including REM AHI and NREM AHI
  • Wearable Belun Ring (BLR-100X) for data collection
  • Measures Oxygen Saturation (SpO2), Pulse Rate (PR), Heart Rate Variability (HRV), and Actigraphy
  • Cableless design for patient comfort and minimal sleep disturbance
  • Enables multiple-night analyses for enhanced accuracy
  • Medical-grade accuracy validated in clinical trials
  • Cloud-based platform for data analysis and reporting

Use Cases

  • In-home sleep apnea testing and diagnosis
  • Monitoring post-treatment effectiveness of Obstructive Sleep Apnea (OSA)
  • Evaluating sleep-related breathing disorders in adult patients
  • Assessing sleep quality and complete sleep architecture
  • Providing data for personalized treatment options
  • Identifying undiagnosed cases of sleep apnea

What Physicians Need to Know

EEG Interpretation AI (Sleep Staging)
The Belun Sleep System BLS-100 employs advanced deep-learning algorithms to accurately classify sleep stages into Wake, NREM, and REM, a function traditionally derived from EEG in polysomnography. It achieves 90% accuracy for REM detection and 82% for NREM.
Neurodegenerative Disease Screening (Indirect Relevance)
The system provides Heart Rate Variability (HRV) analysis as a surrogate marker for autonomic nervous system (ANS) function during sleep. Impaired autonomic function, which can be assessed through HRV, is linked to various health risks and can be relevant to understanding broader physiological changes that may accompany certain neurodegenerative conditions, though it is not a direct screening tool for neurodegenerative diseases.
Mobile Notification System
While the BLS-100 itself is a sleep system, the broader Belun remoVital monitoring system, which incorporates the Belun Ring, offers a real-time remote vital signs monitoring system with an alert system. This system is designed to notify caretakers of abnormal changes in vital signs, enabling timely medical support and remote patient condition monitoring.
Physician Tip

The Belun Sleep System BLS-100 is an FDA-cleared, AI-powered wearable ring primarily designed for the evaluation of moderate to severe obstructive sleep apnea (OSA) and accurate sleep stage classification (Wake, NREM, REM) in a home setting. Physicians can leverage its multi-night testing capability for comprehensive trend analysis of OSA severity and autonomic nervous system responses. It's a valuable tool for convenient, patient-compliant home sleep apnea testing, offering clinically validated data for diagnosis and monitoring. It is not intended for acute neurological event detection or brain imaging analysis.

The Belun Sleep System BLS-100 utilizes proprietary deep-learning algorithms for data analysis, generating clinical reports in PDF format. Data is uploaded to a cloud for AI analysis (Belun Sleep AI). The device is part of an ecosystem that includes the Belun Management Software for healthcare professionals. Its integration into the broader Belun remoVital real-time remote vital signs monitoring system suggests capabilities for seamless data flow and alert generation for comprehensive patient management.

Details

Category Neurology AI, Wearables & Remote Monitoring (RPM)
Pricing Starts at $299.00 usd for hardware plus $85/month/device for ai-scoring subscription.
  • Belun Ring Hardware: $299.00 USD; Monthly Subscription for AI-scoring: $85/month/device; Annual Subscription (Singapore): $2,400.00 SGD
DeploymentWearable device (Belun Ring), standalone PC software (Belun Sleep AI), and cloud-based platform.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Belun Sleep System BLS-100 received FDA 510(k) clearance (K222579) on February 23, 2023, for in-home sleep apnea tests, intended to aid in evaluating moderate to severe sleep-related breathing disorders in adult patients suspected of sleep apnea.
Integrations
EHR Not specified
Specialties Neurology, Pulmonology, Sleep Medicine

What the Web Says

The Belun Sleep System BLS-100 is an FDA-cleared, AI-powered wearable ring designed for home sleep apnea testing (HSAT) and sleep stage classification. It offers a comfortable and convenient alternative to traditional in-lab polysomnography (PSG) by capturing high-resolution physiological data through a minimalist ring form factor. Clinical studies have shown a strong correlation between the Belun Ring's results and gold-standard PSG for detecting obstructive sleep apnea (OSA) and categorizing sleep stages.

Overall: Positive

Strengths

  • FDA 510(k) cleared for both device and AI software for sleep apnea diagnosis and sleep stage classification.
  • High diagnostic accuracy for moderate-to-severe OSA and sleep stage identification (Wake, NREM, REM).
  • Comfortable, lightweight, and cableless ring design, minimizing sleep disturbance.
  • Supports multi-night testing, which helps reduce the 'first-night effect' and averages out night-to-night variability for greater accuracy.
  • Easy to use, with 100% of patients in trials completing the test without professional assistance.
  • Provides comprehensive sleep architecture data, including AHI, sleep efficiency, and REM/NREM percentages.

Limitations

  • Requires an active monthly subscription for AI-scoring, increasing long-term costs.
  • May underestimate mild OSA cases, though it has excellent specificity for severe OSA.
  • Limited specificity for mild OSA.
  • Does not offer all-day tracking.
  • Needs more frequent charging compared to some other options.
  • Requires at least 6 hours of uninterrupted recording for accurate sleep parameters.

Based on reviews from: MedGrade, PubMed, Belun Technology, Sleep Review, ClinicalTrials.gov, ResearchGate, Reddit, Forbes Vetted, YouTube

Last updated: 2026-07-17

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Press & Coverage

RadAI Slice
Belun Sleep System BLS-100 | FDA Radiology AI Device - X-ray Interpreter
The Belun Sleep System BLS-100 is a wearable device for adults suspected of sleep apnea, collecting biophysical signals via a sensor ring and analyzing them with AI-powered software to assess sleep-related breathing disorders. It received FDA 510(k) clearance on February 23, 2023, for use in both clinical and home settings under the direction of a healthcare professional.
2023-02
Belun Technology
FDA-cleared Belun Sleep System may speed up OSA diagnosis for 1 billion population
Belun Technology announced FDA 510(k) clearance for its Belun Sleep System BLS-100 as the world's first AI-enabled wearable ring for obstructive sleep apnea (OSA) diagnosis. The company believes this comfortable and easy-to-use platform can accelerate OSA diagnosis for millions worldwide, potentially reducing medical expenditures.
2023-03
Belun Technology
Belun Sleep System has received positive responses for its medical-grade sleep stages
The Belun Sleep System, with its FDA 510(k) clearance as the first AI-enabled medical-grade wearable ring for sleep apnea diagnosis with sleep stages, has garnered positive feedback from medical professionals. It has been clinically validated to provide accurate AHI, sleep stages, and autonomic nervous system response, aiding in personalized treatment plans.
2023-04
PubMed (Sleep Health)
Belun Ring (Belun Sleep System BLS-100): Deep learning-facilitated wearable enables obstructive sleep apnea detection, apnea severity categorization, and sleep stage classification in patients suspected of obstructive sleep apnea - PubMed
This peer-reviewed article details the evaluation of the Belun Ring with second-generation deep learning algorithms for OSA detection, severity categorization, and sleep stage classification. The study found that the Belun Ring detected OSA with good accuracy and showed moderate-to-substantial agreement in categorizing OSA severity and classifying sleep stages compared to in-lab polysomnography.
2023-06
Oxford Academic (SLEEP)
0517 Integrating Body Sensor into a Wearable Platform to Enhance the Identification of Central and Mixed Apneas | SLEEP | Oxford Academic
This preliminary analysis explores the integration of a novel subxiphoid sensor, Belun Cor, with the FDA-cleared Belun Sleep System (BLS-100) to enhance the identification of central and mixed apneas. Early findings suggest promising performance in detecting apnea events with central components.
2024-04
JMIR Publications
Detection of Sleep Apnea Using Wearable AI: Systematic Review and Meta-Analysis
This systematic review and meta-analysis on wearable AI for sleep apnea detection cites the Belun Ring (Belun Sleep System BLS-100) as a deep learning-facilitated wearable enabling obstructive sleep apnea detection, apnea severity categorization, and sleep stage classification. The review highlights the potential of wearable AI in identifying and classifying sleep apnea, though noting current performance is suboptimal for routine clinical use.
2024-09
Sleep Review
Sleep Rings Go Full Circle - Sleep Review
This article discusses the expanding role of sleep rings in sleep monitoring, highlighting the Belun Ring (BLS-100) as an FDA-cleared AI-powered wearable that has generated over 50,000 reports since its launch in 2023. It emphasizes the ring's discreet form factor, ease of use, and its application in dental sleep practices and mental health evaluations.
2025-03
MedGrade
Belun Ring BLS-100 Review: Clinical AI in a Medical-Grade Wearable - MedGrade
This review positions the Belun Ring (BLS-100) as a significant advancement in home sleep apnea testing, being the first FDA-cleared AI-powered wearable of its kind. It captures high-resolution PPG and accelerometry data, enabling its deep-learning algorithms to accurately identify respiratory events and categorize sleep stages with strong correlation to polysomnography.
2026-03

Videos

Product demos, reviews, and walkthroughs for Belun Sleep System BLS-100.

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Frequently Asked Questions

The Belun Sleep System BLS-100 employs proprietary deep-learning algorithms to provide clinically validated sleep stages (Wake, NREM, REM) and estimate the Apnea-Hypopnea Index (bAHI). It measures biophysical parameters including photoplethysmography (PPG), oxygen saturation (SpO2), pulse rate (PR), heart rate variability (HRV), and 3-axis actigraphy from a wearable ring sensor.
The Belun Sleep System BLS-100 is FDA 510(k) cleared for both the device and its AI software for in-home sleep apnea tests, intended for use under the direction of a Healthcare Professional. As a medical device, it adheres to regulatory standards for data handling, with data stored on the ring and uploaded to a cloud for AI analysis, generating professional reports.
The BLS-100 shows a strong correlation with gold-standard polysomnography (PSG) for AHI (r = 0.89) and total sleep time (r = 0.94), with high accuracy for moderate-to-severe OSA and sleep stage classification. Its cableless, lightweight ring design offers superior patient comfort and ease of use, facilitating multi-night testing which can reduce the 'first-night effect' often seen with in-lab PSG.
While effective for moderate to severe OSA, the Belun Sleep System BLS-100 may underestimate mild cases and has shown some instances of misclassification in severity categorization. Some studies suggest its utility might be stronger as a confirmatory tool rather than a primary screening method for all OSA severities.
The device itself has a price point (e.g., $129), but an active monthly subscription for AI scoring is required, which increases long-term costs for practitioners. While generally eligible for HSA/FSA, insurance coverage can vary by provider and plan, so direct verification is recommended.
The system is FDA 510(k) cleared and clinically validated in both U.S. and Asian populations, demonstrating high accuracy (e.g., 0.89 for AHI u2265 15, 0.91 for AHI u2265 30) and strong agreement with PSG. It achieves high accuracy in sleep stage identification, with 90% for REM and 82% for NREM sleep.
The Belun Sleep System BLS-100 is intended for adult patients suspected of moderate to severe sleep-related breathing disorders and is prescribed by a Healthcare Professional. Clinical trials have validated its robust generalizability even in patients with comorbidities, though it's not intended for over-the-counter use.

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Suggest an Edit → | Last Verified: 2026-04-17 | First Added: 2026-04-17
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