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	<title>FDA Archives - Sleep Apnea Centre</title>
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		<title>FDA-cleared Belun Sleep System may speed up OSA diagnosis for 1 billion population </title>
		<link>https://sac.hk/2023/03/02/fda_osa-diagnostic-device/</link>
		
		<dc:creator><![CDATA[Maggie Lo]]></dc:creator>
		<pubDate>Wed, 01 Mar 2023 21:51:49 +0000</pubDate>
				<category><![CDATA[All]]></category>
		<category><![CDATA[Blog]]></category>
		<category><![CDATA[Chronic Disease]]></category>
		<category><![CDATA[Health]]></category>
		<category><![CDATA[Monitoring]]></category>
		<category><![CDATA[OSA]]></category>
		<category><![CDATA[Ring]]></category>
		<category><![CDATA[SLEEP]]></category>
		<category><![CDATA[Sleep]]></category>
		<category><![CDATA[FDA]]></category>
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					<description><![CDATA[<p>Belun Technology has just received FDA 510(k) clearance for its Belun Sleep System as the World's FIRST wearable ring for obstructive sleep apnea (OSA) using AI. Belun Sleep System, which is comfortable and easy to use, is believed to speed up the diagnosis of 936 million worldwide with moderate to severe OSA. &#8230; </p>
<p><a href="https://sac.hk/2023/03/02/fda_osa-diagnostic-device/" class="more-link">Continue reading<span class="screen-reader-text">FDA-cleared Belun Sleep System may speed up OSA diagnosis for 1 billion population </span></a></p>
<p>The post <a rel="nofollow" href="https://sac.hk/2023/03/02/fda_osa-diagnostic-device/">FDA-cleared Belun Sleep System may speed up OSA diagnosis for 1 billion population </a> appeared first on <a rel="nofollow" href="https://sac.hk">Sleep Apnea Centre</a>.</p>
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<p class="has-text-align-justify wp-block-paragraph">Belun Technology has just received&nbsp;<strong>FDA 510(k) clearance</strong>&nbsp;(K-document: K222579) from the US Food and Drug Administration (FDA) for its Belun Sleep System as the<strong>&nbsp;World&#8217;s First wearable ring for obstructive sleep apnea (OSA) using AI</strong>. <a href="https://sac.hk/2022/05/28/belun-sleep-health-platform/">Belun Sleep Platform</a>, which is comfortable and easy to use, is believed to speed up the diagnosis of 936 million worldwide with moderate to severe OSA<sup>1</sup>. It may result in massive savings on medical expenditures for chronic disease management&nbsp;of the aging population.&nbsp;&nbsp;</p>



<p class="wp-block-paragraph"></p>



<p class="wp-block-paragraph"><strong>Keep people healthy with our preventive healthcare data</strong></p>



<p class="has-text-align-justify wp-block-paragraph">Belun&#8217;s CEO, Dr. Lydia Leung, shared: &#8220;we hope to facilitate home sleep tests for identifying undiagnosed OSA. Research shows sleep health is critical for the overall immune system &amp; treatment effectiveness of chronic diseases.&#8221; The company is expanding towards Preventive Healthcare from the original sleep health. The new direction is an insight found from collaborating with worldwide specialists. Since the launch of our 1st generation Belun Ring in 2018, it has been gradually adopted in other research on long-term diseases, including stroke, hypertension, insomnia, dementia, etc. </p>



<blockquote class="wp-block-quote is-layout-flow wp-block-quote-is-layout-flow">
<p class="wp-block-paragraph"><strong>&#8220;Our new company direction results from the co-created insights after collaborating with worldwide researchers. Sleep takes up so much human time, but we know little about it. Our vision is to keep people healthy with our preventive healthcare data.&#8221;</strong></p>
<cite>Lydia Leung, CEO of Belun Technology </cite></blockquote>



<p class="wp-block-paragraph"></p>



<p class="wp-block-paragraph"><strong>Worldwide obesity epidemic &amp; the aging population</strong></p>



<p class="has-text-align-justify wp-block-paragraph">The sedentary lifestyle of people has led to an increasing prevalence of cardiovascular disease, poor sleep patterns, evaluated stress &amp; obesity. OSA is common in patients with high BMI. Therefore, the&nbsp;<strong><u>worldwide obesity epidemic</u></strong>&nbsp;and the<strong><u>&nbsp;aging population demographic</u></strong>&nbsp;will likely contribute to the rising global prevalence of OSA. According to the World Economic Forum,&nbsp;<strong><u>1 in 3 adults</u></strong>&nbsp;worldwide will suffer from 2 or more chronic conditions, leading to annual healthcare costs with&nbsp;<strong>an 80-300%&nbsp;</strong>increment<sup>2</sup>. World Health Organization estimates a projected 10 million health workers shortfall by 2030<sup>3</sup>. Researchers predicted demand for healthcare workers will increase to 80 million by 2030, but supply will only reach 65 million, creating a healthcare worker deficit of 15 million. The anticipated shortage requires some immediate actions, or access to primary healthcare would be at risk.&nbsp;</p>



<p class="wp-block-paragraph"></p>



<figure class="wp-block-image size-large"><img fetchpriority="high" decoding="async" width="900" height="504" src="https://i0.wp.com/sac.hk/wp-content/uploads/2023/03/worldmap-OSA-prevalencelancet-respir-med-2019.png?resize=900%2C504&#038;ssl=1" alt="" class="wp-image-1551" srcset="https://i0.wp.com/sac.hk/wp-content/uploads/2023/03/worldmap-OSA-prevalencelancet-respir-med-2019.png?resize=1024%2C574&amp;ssl=1 1024w, https://i0.wp.com/sac.hk/wp-content/uploads/2023/03/worldmap-OSA-prevalencelancet-respir-med-2019.png?resize=300%2C168&amp;ssl=1 300w, https://i0.wp.com/sac.hk/wp-content/uploads/2023/03/worldmap-OSA-prevalencelancet-respir-med-2019.png?resize=768%2C431&amp;ssl=1 768w, https://i0.wp.com/sac.hk/wp-content/uploads/2023/03/worldmap-OSA-prevalencelancet-respir-med-2019.png?resize=1536%2C861&amp;ssl=1 1536w, https://i0.wp.com/sac.hk/wp-content/uploads/2023/03/worldmap-OSA-prevalencelancet-respir-med-2019.png?resize=2048%2C1148&amp;ssl=1 2048w, https://i0.wp.com/sac.hk/wp-content/uploads/2023/03/worldmap-OSA-prevalencelancet-respir-med-2019.png?w=1800&amp;ssl=1 1800w, https://i0.wp.com/sac.hk/wp-content/uploads/2023/03/worldmap-OSA-prevalencelancet-respir-med-2019.png?w=2700&amp;ssl=1 2700w" sizes="(max-width: 900px) 100vw, 900px" data-recalc-dims="1" /><figcaption class="wp-element-caption">Lancet report<sup>1</sup> &#8211; Prevalence of OSA in different countries. AHI=apnoea-hypopnoea index<br></figcaption></figure>



<p class="wp-block-paragraph"><strong>PPG-based wearable with medical accuracy</strong></p>



<p class="has-text-align-justify wp-block-paragraph">Belun&#8217;s CEO, Lydia Leung, shared: &#8220;<a href="https://sac.hk/2022/05/29/belun-personal-sleep-monitoring-device/">Belun® Ring</a> is a user and environmentally friendly PPG-based wearable with medical accuracy. Belun will offer a superb convenient option that may bring disruption to the sleep health market &amp; encourage suspected patients to take action and kick start their treatment journey.&#8221; <strong>According to AASM<sup>4</sup>, &#8220;ubiquitous availability of PPG technology may allow for OSA diagnosis at scale.&#8221; There is &#8220;an increased interest in new technologies with therapeutic potential.&#8221;</strong></p>



<p class="wp-block-paragraph"></p>



<p class="wp-block-paragraph"><strong>Chronic Disease Management via AI Preventive Healthcare </strong></p>



<p class="has-text-align-justify wp-block-paragraph">Belun&#8217;s vision is to help people better manage their chronic diseases through artificial intelligence and big data analytics to alleviate medical expenditures due to the aging population. Our solution allows caregivers and patients to follow their treatment effectiveness, select personalized solutions, and enhance treatment compliance. Lydia further shared: &#8220;Long-term monitoring using medical-grade wearables can help people to identify abnormalities earlier to achieve preventive healthcare.&#8221;&nbsp;</p>



<p class="wp-block-paragraph"></p>


<div class="wp-block-image">
<figure class="alignleft size-full"><img decoding="async" width="400" height="200" src="https://i0.wp.com/sac.hk/wp-content/uploads/2023/03/FDA-cleared-Belun-Sleep-System.png?resize=400%2C200&#038;ssl=1" alt="Belun® Ring is adopted as a digital sleep diary as part of the CBT-I treatment in Hong Kong" class="wp-image-1552" srcset="https://i0.wp.com/sac.hk/wp-content/uploads/2023/03/FDA-cleared-Belun-Sleep-System.png?w=400&amp;ssl=1 400w, https://i0.wp.com/sac.hk/wp-content/uploads/2023/03/FDA-cleared-Belun-Sleep-System.png?resize=300%2C150&amp;ssl=1 300w" sizes="(max-width: 400px) 100vw, 400px" data-recalc-dims="1" /><figcaption class="wp-element-caption">Belun<sup>®</sup>&nbsp;Ring is adopted as a digital sleep diary as part of the <br>CBT-I treatment in Hong Kong</figcaption></figure>
</div>


<p class="wp-block-paragraph"><strong>Worldwide partnership for the OSA markets </strong></p>



<p class="has-text-align-justify wp-block-paragraph">To cope with the massive market, Belun has teamed up with global partners to customize solutions for local communities in different countries. Some sleep lab groups in the United States will launch the Belun Sleep System to cater to both the OSA &amp; insomnia markets. For the Indian market, Belun will collaborate with renowned neurologists &amp; sleep specialists to tap into the millions of untreated OSA. The two markets have 104 million suspected OSA, according to the Lancet report<sup>1</sup>.</p>



<p class="wp-block-paragraph"></p>



<p class="wp-block-paragraph"><strong>Partnering with Belun</strong>&nbsp;:</p>



<p class="has-text-align-justify wp-block-paragraph">Up to now, over a hundred organizations, including HK hospital authority hospitals, medical groups, clinic groups, dentists, and elderly centers selected to use the <a href="https://sac.hk/2022/05/28/belun-sleep-health-platform/">Belun Sleep System</a>, <a href="https://sac.hk/2022/05/29/belun-personal-sleep-monitoring-device/">Belun® Ring</a> and Sleep App, and <a href="https://sac.hk/2022/05/29/belun-removital-monitoring-system/">Belun® remoVital monitoring system</a>. 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” (<a href="https://jcsm.aasm.org/doi/10.5664/jcsm.8592" target="_blank" rel="noreferrer noopener">https://jcsm.aasm.org/doi/10.5664/jcsm.8592</a>) and 2) “Detection of obstructive sleep apnea using Belun Sleep Platform wearable with neural network based algorithm and its combined use with STOP-Bang questionnaire” (<a href="https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0258040" target="_blank" rel="noreferrer noopener">https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0258040</a>). </p>



<p class="wp-block-paragraph"></p>



<p class="has-text-align-justify wp-block-paragraph">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:</p>


<div class="wp-block-jetpack-contact-form"><a href="https://sac.hk/2023/03/02/fda_osa-diagnostic-device/" target="_blank" rel="noopener noreferrer">Submit a form.</a></div>


<p class="wp-block-paragraph"><strong>References</strong></p>



<p class="wp-block-paragraph">1.A.V, Benjafield et al, Lancet Respiratory Medicine, 2019; 2. Susanna Ng et al, PLOS One, 2015</p>



<p class="wp-block-paragraph">2.&nbsp;<a href="https://www.weforum.org/agenda/2017/12/healthcare-future-multiple-chronic-disease-ncd/">https://www.weforum.org/agenda/2017/12/healthcare-future-multiple-chronic-disease-ncd</a><a href="https://www.weforum.org/agenda/2017/12/healthcare-future-multiple-chronic-disease-ncd/">/</a></p>



<p class="wp-block-paragraph">3.&nbsp;<a href="https://www.who.int/news/item/02-06-2022-global-strategy-on-human-resources-for-health--workforce-2030">https://www.who.int/news/item/02-06-2022-global-strategy-on-human-resources-for-health&#8211;workforce-2030</a></p>



<p class="wp-block-paragraph">4.&nbsp;<a href="https://aasm.org/wp-content/uploads/2022/05/Tech-Committee-Report.pdf">https://aasm.org/wp-content/uploads/2022/05/Tech-Committee-Report.pdf</a></p>
<p>The post <a rel="nofollow" href="https://sac.hk/2023/03/02/fda_osa-diagnostic-device/">FDA-cleared Belun Sleep System may speed up OSA diagnosis for 1 billion population </a> appeared first on <a rel="nofollow" href="https://sac.hk">Sleep Apnea Centre</a>.</p>
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