{"id":5668468,"date":"2024-10-29T16:36:09","date_gmt":"2024-10-29T08:36:09","guid":{"rendered":"https:\/\/beluntech.com\/?p=5668468"},"modified":"2025-10-22T14:55:11","modified_gmt":"2025-10-22T06:55:11","slug":"regulatory_approval_india","status":"publish","type":"post","link":"https:\/\/beluntech.com\/zh\/posts\/2024\/10\/regulatory_approval_india\/","title":{"rendered":"\u500d\u9748\u7761\u7720\u7cfb\u7d71\u7372\u5370\u5ea6\u6279\u51c6\u70ba\u8a8d\u53ef\u7684\u4eba\u5de5\u667a\u80fd\u8a3a\u65b7\u5de5\u5177"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><div class=\"vc_row wpb_row vc_row-fluid\"><div class=\"wpb_column vc_column_container vc_col-sm-12\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"norebro-text-sc\" \r\n\tid=\"norebro-custom-69ea14a32dae6\" \r\n\t \r\n\t>\r\n\r\n\t<p class=\"translation-block\">\u500d\u9748\u7761\u7720\u7cfb\u7d71\u5df2\u7372\u5f97\u300c\u5370\u5ea6\u885b\u751f\u8207\u5bb6\u5ead\u798f\u5229\u90e8\u300d\u7684\u6279\u51c6\u7528\u65bc\u8a3a\u65b7\u963b\u585e\u6027\u7761\u7720\u7a92\u606f\u75c7<strong>(Obstructive Sleep Apnea OSA)<\/strong>\u4e26\u5206\u985e\u7761\u7720\u968e\u6bb5\u3002\u500d\u9748\u7761\u7720\u7cfb\u7d71\u662f\u4e00\u7a2e\u57fa\u65bc\u4eba\u5de5\u667a\u6167\u7684\u8a3a\u65b7\u7cfb\u7d71\u3002\u53ef\u70ba\u6578\u767e\u842c\u60a3\u6709\u7761\u7720\u969c\u7919\u7684\u5370\u5ea6\u4eba\u63d0\u4f9b\u4e86\u66f4\u4fbf\u6377\u548c\u53ef\u53ca\u7684\u8a3a\u65b7\u89e3\u6c7a\u65b9\u6848\u3002<\/p>\n<p><strong>\u6539\u5584\u6578\u767e\u842c\u4eba\u7684\u7761\u7720\u5065\u5eb7<\/strong><\/p>\n<p class=\"translation-block\">\u6839\u64da\u4f30\u8a08\uff0c\u5168\u7403<strong>30\u81f369\u6b72<\/strong>\u7684\u6210\u5e74\u4eba\u7576\u4e2d\uff0c\u7d04\u6709<strong>9.36\u5104\u4eba<sup>1<\/sup><\/strong>\u60a3\u6709\u7761\u7720\u7a92\u606f\u75c7\u3002\u7814\u7a76\u986f\u793a\u5728\u5370\u5ea6\uff0c\u6210\u5e74\u4eba\u4e2d\u60a3\u6709\u963b\u585e\u6027\u7761\u7720\u7a92\u606f\u75c7(OSA)\u7684\u767c\u75c5\u7387\uff0c\u6703\u96a8\u8457\u5730\u5340\u548c\u6027\u5225\u800c\u6709\u6240\u4e0d\u540c\uff0c\u4ecb\u4e4e\u65bc<strong>4.4%\u523013.7%<\/strong>\u4e4b\u9593\uff0c\u5c24\u5176\u662f\u7537\u6027\u7684\u98a8\u96aa\u66f4\u9ad8\uff0c\u767c\u75c5\u7387\u53ef<strong>\u591a\u905419.7%<sup>2<\/sup><\/strong>\uff0c\u4f54\u4e86\u76f8\u7576\u5927\u7684\u4eba\u53e3\u6bd4\u4f8b\u3002<\/p>\n<p><em>\u300c\u9019\u662f\u5370\u5ea6\u5728\u8a3a\u65b7\u7761\u7720\u969c\u7919\u65b9\u9762\u7684\u4e00\u9805\u91cd\u5927\u7a81\u7834\u3002\u300d\u500d\u9748\u79d1\u6280\u7684\u7e3d\u88c1\u6881\u7acb\u6167\u535a\u58eb\u5206\u4eab\u9053\u3002\u300c\u96a8\u8457\u500d\u9748\u7761\u7720\u7cfb\u7d71\u9032\u5165\u5370\u5ea6\u5e02\u5834\uff0c\u6211\u5011\u53ef\u66f4\u9032\u4e00\u6b65\u5e6b\u52a9\u4fc3\u9032\u7761\u7720\u7a92\u606f\u75c7\u7684\u65e9\u671f\u8a3a\u65b7\u548c\u6cbb\u7642\uff0c\u5f9e\u800c\u70ba\u6578\u4ee5\u767e\u842c\u8a08\u7684\u672a\u5f97\u5230\u61c9\u6709\u6cbb\u7642\u7684\u7761\u7720\u969c\u7919\u60a3\u8005\u5e36\u4f86\u66f4\u5feb\u901f\u3001\u66f4\u6e96\u78ba\u7684\u8a3a\u65b7\u548c\u66f4\u597d\u7684\u6cbb\u7642\u7d50\u679c\u3002\u300d<\/em><\/p>\n<p><strong>\u4fbf\u6377\u4e14\u6613\u65bc\u7372\u5f97\u7684\u8a3a\u65b7<\/strong><\/p>\n<p>\u963b\u585e\u6027\u9032\u7761\u7720\u7a92\u606f\u75c7\uff08OSA\uff09\u662f\u4e00\u7a2e\u5728\u7761\u7720\u671f\u9593\u5f71\u97ff\u547c\u5438\u7684\u56b4\u91cd\u75be\u75c5\uff0c\u73fe\u4ee3\u7684\u90fd\u5e02\u4eba\u7531\u65bc\u80a5\u80d6\u554f\u984c\u52a0\u5287\u3001\u58d3\u529b\u589e\u5927\u548c\u751f\u6d3b\u65b9\u5f0f\u7684\u6539\u8b8a\uff0c\u9019\u7a2e\u7761\u7720\u75be\u75c5\u5728\u5370\u5ea6\u8b8a\u5f97\u8d8a\u4f86\u8d8a\u666e\u904d\u3002\u50b3\u7d71\u4e0a\uff0c\u8a3a\u65b7\u901a\u5e38\u9700\u8981\u60a3\u8005\u5728\u5c08\u696d\u7761\u7720\u8a3a\u6240\u904e\u591c\uff0c\u9019\u5c0d\u60a3\u8005\u4f86\u8aaa\u53ef\u80fd\u8cbb\u7528\u9ad8\u6602\u4e14\u96e3\u4ee5\u63a5\u89f8\u3002\u800c\u96a8\u8457\u500d\u9748\u7761\u7720\u7cfb\u7d71\u7684\u7372\u5f97\u5be9\u6279\uff0c\u60a3\u8005\u73fe\u5728\u53ef\u4ee5\u5728\u81ea\u5bb6\u8212\u9069\u7684\u74b0\u5883\u4e2d\u9032\u884c\u7761\u7720\u7a92\u606f\u75c7\u7684\u8a3a\u65b7\u3002<\/p>\n<p>\u65b0\u7372\u5f97\u5be9\u6279\u7684\u500d\u9748\u7761\u7720\u7cfb\u7d71\uff0c\u5229\u7528\u4eba\u5de5\u667a\u80fd\uff08AI\uff09\u548c\u985e\u4f3c\u65bcPAT\u7684\u5149\u5b78\u6280\u8853\uff0c\u4f86\u6536\u96c6\u8108\u640f\u7387\u3001\u5fc3\u7387\u8b8a\u7570\u6027\u3001\u8840\u6c27\u98fd\u548c\u5ea6\uff08SpO2\uff09\u548c\u80a2\u9ad4\u6d3b\u52d5\u7b49\u751f\u7406\u6578\u64da\uff0c\u4ee4\u91ab\u7642\u4eba\u54e1\u53ef\u4ee5\u9060\u7a0b\u76e3\u6e2c\u5230\u60a3\u8005\u7684\u547c\u5438\u66ab\u505c\u6307\u6578\uff08Apnea Hyponea Index AHI\uff09\u3001\u8840\u6c27\u98fd\u548c\u5ea6\uff08Oxygen Saturation levels SpO2\uff09\u3001\u8108\u640f\u7387\u548c\u81ea\u5f8b\u795e\u7d93\u7cfb\u7d71\uff08Autonomic Nervous System ANS\uff09\uff0c\u800c\u7121\u9700\u60a3\u8005\u524d\u5f80\u7761\u7720\u8a3a\u6240\u3002\u7279\u5225\u662f\u5728\u5370\u5ea6\u6bd4\u8f03\u504f\u9060\u4e14\u91ab\u7642\u670d\u52d9\u6709\u9650\u7684\u5730\u5340\uff0c\u500d\u9748\u7cfb\u7d71\u70ba\u8a72\u7b49\u5730\u5340\u7684\u60a3\u8005\u63d0\u4f9b\u4e86\u7c21\u55ae\u5be6\u60e0\u7684\u8a3a\u65b7\u65b9\u5f0f\u3002<\/p>\n<p><strong>\u500d\u9748\u7761\u7720\u7cfb\u7d71\u7684\u4e3b\u8981\u512a\u9ede\uff1a<\/strong><\/p>\n<ul>\n<li><strong>\u8212\u9069\u6027<\/strong>\uff1a\u60a3\u8005\u53ef\u4ee5\u5728\u81ea\u5bb6\u9032\u884c\u6e2c\u8a66\uff0c\u4ee4\u6240\u5f97\u6578\u64da\u65bc\u60a3\u8005\u65e5\u5e38\u7761\u7720\u74b0\u5883\u4e2d\u6536\u96c6\u3002<\/li>\n<li><strong>\u7d93\u6fdf\u6027<\/strong>\uff1a\u5728\u5bb6\u6e2c\u8a66\u964d\u4f4e\u4e86\u7684\u8cbb\u7528\u6210\u672c\uff0c\u4f7f\u66f4\u591a\u4eba\u8ca0\u64d4\u5f97\u5230\u3002<\/li>\n<li><strong>\u53ca\u6642\u8a3a\u65b7<\/strong>\uff1a\u66f4\u5feb\u901f\u7684\u8a3a\u65b7\u7d50\u679c\u4fc3\u4f7f\u66f4\u65e9\u7684\u6cbb\u7642\uff0c\u5f9e\u800c\u964d\u4f4e\u4e86\u60a3\u4e0a\u5fc3\u81df\u75c5\u3001\u7cd6\u5c3f\u75c5\u548c\u9ad8\u8840\u58d3\u7b49\u76f8\u95dc\u75be\u75c5\u7684\u98a8\u96aa\u3002<\/li>\n<li><strong>\u64f4\u5c55\u8fb2\u6751\u5730\u5340\u8986\u84cb<\/strong>\uff1a\u500d\u9748\u8a2d\u5099\u7684\u9748\u6d3b\u6027\u52a0\u5f37\u4e86\u91ab\u7642\u63d0\u4f9b\u8005\u7684\u670d\u52d9\u8986\u84cb\u7bc4\u570d\uff0c\u4ee4\u65bc\u91ab\u7642\u8cc7\u6e90\u5331\u4e4f\u5730\u5340\u7684\u60a3\u8005\u90fd\u53ef\u7372\u5f97\u7761\u7720\u5065\u5eb7\u7684\u8a3a\u65b7\u3002<\/li>\n<\/ul>\n<p><strong>\u64f4\u5c55\u5370\u5ea6\u7684\u91ab\u7642\u5275\u65b0<\/strong><\/p>\n<p>\u5370\u5ea6\u653f\u5e9c\u8f03\u65e9\u524d\u901a\u904e\u8981\u904b\u7528\u5275\u65b0\u79d1\u6280\u6539\u5584\u91ab\u7642\u8a3a\u65b7\u670d\u52d9\u4ee4\u5176\u66f4\u5ee3\u6cdb\u63a8\u884c\uff0c\u6279\u51c6\u63a1\u7528\u500d\u9748\u7761\u7720\u7cfb\u7d71\u5be6\u6709\u52a9\u9054\u6210\u6b64\u76ee\u6a19\u3002\u70ba\u914d\u5408\u6b64\u8a08\u5283\uff0c\u500d\u9748\u5c07\u50be\u529b\u8207\u7576\u5730\u91ab\u7642\u5718\u968a\u5408\u4f5c\uff0c\u4ee4\u5176\u7cfb\u7d71\u9806\u5229\u6574\u5408\u5230\u65e5\u5e38\u91ab\u7642\u7684\u4f7f\u7528\u7576\u4e2d\u3002<\/p>\n<p><em>\u300c\u5370\u5ea6\u7684\u91ab\u7642\u7cfb\u7d71\u6b63\u5728\u7d93\u6b77\u5feb\u901f\u8b8a\u9769\uff0c\u6211\u5011\u5f88\u81ea\u8c6a\u80fd\u70ba\u6b64\u51fa\u4e00\u5206\u529b\u3002\u300d\u500d\u9748\u79d1\u6280\u7684\u7e3d\u88c1\u6881\u7acb\u6167\u88dc\u5145\u9053\u3002\u300c\u6211\u5011\u516c\u53f8\u65e8\u5728\u63a8\u5ee3\u9810\u9632\u6027\u91ab\u7642\uff0c\u4ee4\u6240\u6709\u4eba\u90fd\u80fd\u7372\u5f97\u5148\u9032\u7684\u91ab\u7642\u6280\u8853\uff0c\u7b2c\u4e00\u6b65\u4fbf\u662f\u900f\u904e\u8b93\u60a3\u8005\u5728\u5bb6\u4e2d\u9032\u884c\u7761\u7720\u5065\u5eb7\u6aa2\u6e2c\u3002\u300d<\/em><\/p>\n<p><strong>\u6709\u95dc\u500d\u9748\u79d1\u6280\u00a0<\/strong><\/p>\n<p>\u500d\u9748\u79d1\u6280\u5c08\u6ce8\u65bc\u958b\u767c\u91ab\u7642\u7d1a\u53ef\u7a7f\u6234\u8a2d\u5099\u548c\u4eba\u5de5\u667a\u80fd\u89e3\u6c7a\u65b9\u6848\uff0c\u4e26\u63d0\u4f9b\u5f9e\u521d\u6b65\u8a3a\u65b7\u5230\u9577\u671f\u76e3\u6e2c\u7684\u5168\u9762\u7761\u7720\u7a92\u606f\u75c7\u53ca\u5176\u4ed6\u7761\u7720\u969c\u7919\uff08\u5982\u5931\u7720\uff09\u7684\u7ba1\u7406\u3002\u5176\u4eba\u5de5\u667a\u80fd\u662f\u900f\u904e\u7d93\u7f8e\u570b\u3001\u9999\u6e2f\u3001\u65b0\u52a0\u5761\u548c\u53f0\u7063\u7684\u5168\u7403\u7814\u7a76\u6240\u6536\u96c6\u7684\u6578\u5341\u5104\u5065\u5eb7\u6307\u7d0b\u800c\u958b\u767c\uff0c\u65bc\u7d93\u904e\u8a8d\u8b49\u7684\u7761\u7720\u5be6\u9a57\u5ba4\u4e2d\u9032\u884c\u4e86\u81e8\u5e8a\u9a57\u8b49\uff0c\u7121\u8ad6\u786c\u4ef6\u6216\u8edf\u4ef6(\u5305\u62ec\u7761\u7720\u968e\u6bb5\uff09\u5747\u5df2\u7372\u5f97\u7f8e\u570bFDA 510(k)\u8a8d\u8b49\uff0c\u5e6b\u52a9\u91ab\u751f\u548c\u7761\u7720\u5c08\u5bb6\u66f4\u597d\u5730\u4e86\u89e3\u60a3\u8005\u7684\u7761\u7720\u7d50\u69cb\uff0c\u53ef\u7528\u65bc\u7be9\u67e5\u7761\u7720\u5065\u5eb7\u3001\u8a55\u4f30\u9577\u671f\u75c5\u60a3\u8005\u7684\u6cbb\u7642\u6548\u679c\u4e26\u9810\u6e2c\u5065\u5eb7\u98a8\u96aa\u3002<\/p>\n<p>\u8ffd\u8e2a\u4ee5\u4e0b\u793e\u4ea4\u5a92\u9ad4\u4ee5\u7372\u53d6\u6709\u95dc\u6539\u5584\u7761\u7720\u548c\u6162\u6027\u75c5\u7ba1\u7406\u7684\u8cc7\u8a0a\uff1a<\/p>\n<p><a class=\"external-link\" href=\"https:\/\/www.linkedin.com\/company\/belun-technology-co-ltd\" rel=\"nofollow\">LinkedIn<\/a>\u00a0|\u00a0<a class=\"external-link\" href=\"https:\/\/youtube.com\/channel\/UCC5yyJFw0dzC_bwXMp26r6Q\" rel=\"nofollow\">Youtube<\/a>\u00a0|\u00a0<a class=\"external-link\" href=\"https:\/\/www.facebook.com\/beluntech\" rel=\"nofollow\">Facebook<\/a><\/p>\n<p><strong>\u5f15\u6587:<\/strong><\/p>\n<p>1\/ A.V, Benjafield et al, Lancet Respiratory Medicine, 2019; 2. Susanna Ng et al, PLOS One, 2015<\/p>\n<p>2\/\u00a0<a class=\"external-link\" href=\"https:\/\/aasm.org\/wp-content\/uploads\/2022\/05\/Tech-Committee-Report.pdfhttps:\/\/www.resmed.co.in\/blogs\/prevalence-sleep-apnea-india\" rel=\"nofollow\">\u745e\u601d\u9081 Resmed \u5370\u5ea6<\/a><\/p>\n\t\r\n<\/div><\/div><\/div><\/div><\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>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.<\/p>","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[78],"tags":[],"class_list":["post-5668468","post","type-post","status-publish","format-standard","hentry","category-press-release"],"_links":{"self":[{"href":"https:\/\/beluntech.com\/zh\/wp-json\/wp\/v2\/posts\/5668468","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/beluntech.com\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/beluntech.com\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/beluntech.com\/zh\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/beluntech.com\/zh\/wp-json\/wp\/v2\/comments?post=5668468"}],"version-history":[{"count":4,"href":"https:\/\/beluntech.com\/zh\/wp-json\/wp\/v2\/posts\/5668468\/revisions"}],"predecessor-version":[{"id":5668472,"href":"https:\/\/beluntech.com\/zh\/wp-json\/wp\/v2\/posts\/5668468\/revisions\/5668472"}],"wp:attachment":[{"href":"https:\/\/beluntech.com\/zh\/wp-json\/wp\/v2\/media?parent=5668468"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/beluntech.com\/zh\/wp-json\/wp\/v2\/categories?post=5668468"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/beluntech.com\/zh\/wp-json\/wp\/v2\/tags?post=5668468"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}