{"id":23577,"date":"2022-12-14T01:15:00","date_gmt":"2022-12-13T17:15:00","guid":{"rendered":"https:\/\/flcube.com\/?p=23577"},"modified":"2025-01-28T01:27:04","modified_gmt":"2025-01-27T17:27:04","slug":"cryofocus-biotechnologys-rdn-system-gains-fda-breakthrough-therapy-designation","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=23577","title":{"rendered":"Cryofocus Biotechnology’s RDN System Gains FDA Breakthrough Therapy Designation"},"content":{"rendered":"\n

Shanghai-based cryoablation treatment specialist Cryofocus Medtech (Shanghai) Co., Ltd’s in-house developed Cryofocus RDN System, a cryoablation renal denervation product, has obtained breakthrough therapy designation (BTD) status from the US FDA for use in refractory hypertension.<\/p>\n\n\n\n

Regulatory Milestones and Innovations<\/strong>
The Cryofocus RDN System, the first of its kind globally, previously passed novel medical device special review by the National Medical Products Administration (NMPA). Professor Ge Junbo, a CAS academician with Zhongshan Hospital, led this team to complete the world\u2019s first in vivo operation using the Cryofocus RDN System with deep hypothermia in 2015. This product, featuring 360\u00b0 circular ablation, complete nerve injury, precise ablation location, and small endothelial damage, can cover the effective ablation depth, positioning it as a significant advancement in the treatment of refractory hypertension.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

Shanghai-based cryoablation treatment specialist Cryofocus Medtech (Shanghai) Co., Ltd’s in-house developed Cryofocus RDN System, a…<\/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":[3350,69],"class_list":["post-23577","post","type-post","status-publish","format-standard","hentry","category-company","category-medical-device","tag-cryofocus-medtech","tag-cvd"],"yoast_head":"\nCryofocus Biotechnology's RDN System Gains FDA Breakthrough Therapy Designation - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Shanghai-based cryoablation treatment specialist Cryofocus Medtech (Shanghai) Co., Ltd's in-house developed Cryofocus RDN System, a cryoablation renal denervation product, has obtained breakthrough therapy designation (BTD) status from the US FDA for use in refractory hypertension.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=23577\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Cryofocus Biotechnology's RDN System Gains FDA Breakthrough Therapy Designation\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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