{"id":22405,"date":"2025-01-21T17:05:58","date_gmt":"2025-01-21T09:05:58","guid":{"rendered":"https:\/\/flcube.com\/?p=22405"},"modified":"2025-01-21T17:06:00","modified_gmt":"2025-01-21T09:06:00","slug":"huadong-medicines-medibeacon-tgfr-system-receives-fda-marketing-clearance","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=22405","title":{"rendered":"Huadong Medicine’s MediBeacon TGFR System Receives FDA Marketing Clearance"},"content":{"rendered":"\n

China-based Huadong Medicine Co., Ltd (SHE: 000963<\/a>) has announced receiving marketing clearance from the US Food and Drug Administration (FDA) for its MediBeacon Transdermal GFR System (TGFR), a medical device co-developed with US partner MediBeacon Inc. The system is designed to evaluate renal function in adult patients with both impaired and normal kidney function.<\/p>\n\n\n\n

MediBeacon TGFR: System Overview<\/strong>
The MediBeacon TGFR system comprises a monitor, sensors, and Lumitrace (relmapirazin), a non-radioactive, non-iodinated fluorescent GFR tracer. It assesses glomerular filtration rate (GFR) through non-invasive monitoring of fluorescence values of exogenous tracers over time. The system measures the in vivo clearance rate of fluorescent tracers and calculates real-time changes in Lumitrace fluorescence intensity via transdermal sensors placed on the skin surface. This method is unaffected by age, weight, gender, or race, making it a versatile tool for renal function assessment.<\/p>\n\n\n\n

Commercialization and Market Reach<\/strong>
As the world\u2019s first bedside product for renal function assessment in patients with normal or impaired kidney function, the MediBeacon TGFR system is being commercialized by Huadong Medicine in mainland China, Hong Kong, Taiwan, Singapore, Malaysia, and other regions in Asia. The FDA clearance marks a significant milestone in expanding the system\u2019s global reach and enhancing its adoption in clinical settings.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

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

China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced receiving marketing clearance from the US…<\/p>\n","protected":false},"author":1,"featured_media":22406,"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":[7,11],"tags":[114,887],"class_list":["post-22405","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-huadong-medicine","tag-she-000963"],"yoast_head":"\nHuadong Medicine's MediBeacon TGFR System Receives FDA Marketing Clearance - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced receiving marketing clearance from the US Food and Drug Administration (FDA) for its MediBeacon Transdermal GFR System (TGFR), a medical device co-developed with US partner MediBeacon Inc. 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