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Indian Health Authorities Approved Belun Sleep System as Diagnostic Tools for Obstructive Sleep Apnea


Belun Technology - October 29, 2024 - 0 comments

The Belun Sleep System, an AI-enabled system for diagnosing Obstructive Sleep Apnea (OSA) with sleep stages classification, has received approval from the Ministry of Health and Family Welfare India as a diagnostic tool. This clearance allows more convenient and accessible diagnostic solutions for millions of Indians who suffer from sleep disorders.

Advancing Sleep Health for Millions

For individuals aged 30 to 69 years, it is estimated that about 936 million people worldwide1 suffer from some form of OSA. In India specifically, studies show that the prevalence of OSA in adults ranges between 4.4% to 13.7% depending on gender and region. This means a substantial portion of the Indian population in this age group could have OSA, with Indian men being particularly at higher risk, where the condition could affect up to 19.7%2 of males in certain studies​.

“This is a breakthrough in diagnosing sleep disorders in India,” said Lydia Leung, CEO of Belun Technology. “With Belun Sleep System available to the Indian public, we aim to help facilitate early diagnosis and treatment of sleep apnea, resulting in quicker, more accurate & affordable diagnosis and better treatment outcomes for the millions of Indians living with untreated sleep disorders.”

Convenient and Accessible Diagnosis

Obstructive Sleep apnea (OSA), a serious condition that affects breathing during sleep, is becoming increasingly common in India due to rising rates of obesity, stress, and lifestyle changes. Traditionally, diagnosis required overnight stays in specialized sleep clinics, which could be costly and difficult for patients to access. With the approval of Belun Sleep System, patients can now undergo a sleep apnea diagnosis at their own homes comfortably.

The newly-approved Belun Sleep System, with the use of artificial intelligence (AI) and optical technologies similar to PAT to collect physiological parameters such as pulse rate, heart rate variability, oximetry and actigraphy, allowing healthcare professionals to remotely monitor Apnea Hyponea Index (AHI), oxygen saturation levels (SpO2), pulse rate and autonomic nervous system (ANS), without requiring patients to visit a sleep clinic. The system provide a simpler, more affordable way for patients to receive a diagnosis, particularly in areas where access to medical services may be limited.

Key Benefits of Belun Sleep System :

  • Comfort: Tests can be performed in the patient’s own home, allowing for a more natural sleep environment.
  • Affordability: Home testing reduces the cost burden of traditional sleep studies, making it more accessible to a larger population.
  • Timely Diagnosis: Faster diagnostic results enable earlier treatment for sleep apnea, reducing the risk of associated conditions like heart disease, diabetes, and hypertension.
  • Reach in Rural Areas: Belun device empowers healthcare providers to serve patients in underserved areas, expanding the reach of sleep health diagnostics.

Expanding Healthcare Innovation in India

The approval of Belun Sleep System in India aligns with the country’s broader healthcare goals of improving access to diagnostic services through innovative technologies. As part of this initiative, Belun Technology, a data technology provider of sleep health solutions, is committed to working with local healthcare professionals to integrate these tools into regular practice.

“India’s healthcare system is undergoing rapid transformation, and we are proud to be part of this journey,” added Lydia Leung. “By enabling patients to perform these tests at home, we aim to promote preventive healthcare and ensure that advanced medical technologies are accessible to all.”

About Belun Technology 

Belun Technology specializes in AI-powered sleep diagnostic and screening solutions and offers holistic management of sleep apnea and other sleep disorders e.g., insomnia, from initial diagnosis to long-term monitoring. Its AI-powered, medical-grade wearable ring and sleep system has obtained the US FDA 510(k)  for detecting and diagnosing obstructive Sleep Apnea (OSA). The device has also been clinically validated in accredited sleep labs, helping physicians and sleep specialists better understand the patient’s sleep stages to formulate a personalized treatment plan. Headquartered in Asia, Belun’s Preventive Healthcare Solutions is powered by billions of health fingerprints and proprietary AI algorithms collected from global research in the US, Hong Kong, Singapore, Thailand & Taiwan. Their medical-grade wearables & AI solutions for screening sleep health can evaluate treatment effectiveness for patients with chronic disease & predict health risks.

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Sources :

1/ A.V, Benjafield et al, Lancet Respiratory Medicine, 2019; 2. Susanna Ng et al, PLOS One, 2015

2/ RedMed India