{"id":24240,"date":"2022-11-18T00:18:00","date_gmt":"2022-11-17T16:18:00","guid":{"rendered":"https:\/\/flcube.com\/?p=24240"},"modified":"2025-01-31T00:21:32","modified_gmt":"2025-01-30T16:21:32","slug":"bio-heart-bio-receives-ethical-approval-for-iberis-rdn-system-in-hainan","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=24240","title":{"rendered":"Bio-Heart Bio Receives Ethical Approval for Iberis RDN System in Hainan"},"content":{"rendered":"\n

China-based Shanghai Bio-Heart Biological Technology Co., Ltd (HKG: 2185<\/a>) has announced receiving ethical approval from Ruijin Hospital\u2019s Hainan branch for its Iberis multi-electrode renal radiofrequency denervation (RDN) system. The company is on the brink of applying for clinical emergence use with the Hainan Medical Products Administration and Hainan\u2019s health commission.<\/p>\n\n\n\n

Product Profile<\/strong>
Bio-Heart Bio\u2019s RDN product previously obtained CE certification from the European Union in 2016. This certification indicates that the product meets the necessary safety and performance standards, positioning it for potential approval in the Bo\u2019Ao Lecheng Medical Tourism Pilot Zone, in accordance with relevant policies. The Iberis system is designed to treat hypertension through renal denervation, offering a minimally invasive alternative to traditional therapies.<\/p>\n\n\n\n

Future Implications<\/strong>
The ethical approval from Ruijin Hospital\u2019s Hainan branch marks a significant step forward for Bio-Heart Bio in expanding its presence in the Chinese market. The company\u2019s Iberis RDN system is poised to benefit from the growing demand for innovative medical devices in the region, particularly in the treatment of hypertension. This development underscores Bio-Heart Bio\u2019s commitment to advancing medical technology and improving patient outcomes.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

China-based Shanghai Bio-Heart Biological Technology Co., Ltd (HKG: 2185) has announced receiving ethical approval from…<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,22],"tags":[2607,91,2606,38],"class_list":["post-24240","post","type-post","status-publish","format-standard","hentry","category-company","category-medical-device","tag-bio-heart-biological-technology","tag-boao-lecheng-pilot-zone","tag-hkg-2185","tag-market-approval-filings"],"yoast_head":"\nBio-Heart Bio Receives Ethical Approval for Iberis RDN System in Hainan - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Shanghai Bio-Heart Biological Technology Co., Ltd (HKG: 2185) has announced receiving ethical approval from Ruijin Hospital\u2019s Hainan branch for its Iberis multi-electrode renal radiofrequency denervation (RDN) system. 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