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MediBeacon® Transdermal GFR Monitor and Reusable Sensor Receive CE Mark Under European Medical Device Regulation
Globenewswire· 2026-03-31 12:05
Core Viewpoint - MediBeacon Inc., an equity method investment of INNOVATE Corp., has received EU CE Mark certification for its TGFR™ Monitor and TGFR™ Reusable Sensor, confirming compliance with EU Medical Device Regulation standards [1][2] Company Overview - INNOVATE Corp. operates in three key areas: Infrastructure, Life Sciences, and Spectrum, employing approximately 3,700 people across its subsidiaries [4] - MediBeacon specializes in fluorescent tracer agents and transdermal detection technology, holding over 55 U.S. patents and more than 250 patents worldwide [5] Product Details - The TGFR™ System includes the TGFR Monitor, TGFR Reusable Sensor, TGFR Disposable Ring, and Lumitrace (relmapirazin) injection, enabling kidney function assessment through transdermal measurement of fluorescent agent clearance [2][7] - The TGFR Reusable Sensor records 2.5 fluorescent readings per second, while the TGFR Monitor displays average session tGFR readings at the point of care [8] Clinical Implications - The CE Mark certification allows MediBeacon's technology to be utilized in clinical trials across European sites, enhancing its potential for addressing renal complications [2][3] - Dr. Lui Forni, a leader in critical care nephrology, anticipates incorporating transdermal GFR assessments in clinical research in Europe later this year [3]
Transdermal GFR Article Recognized as One of Five 2025 Editors' Choice Articles by Journal of the American Society of Nephrology (JASN)
Globenewswire· 2026-02-10 21:05
Core Insights - INNOVATE Corp. announced that its investment in MediBeacon Inc. has led to the recognition of a peer-reviewed article on transdermal GFR measurement as one of the top five Editor's Choice articles for 2025 by the Journal of the American Society of Nephrology [1][2] Company Overview - INNOVATE Corp. operates in three key areas: Infrastructure, Life Sciences, and Spectrum, employing approximately 3,100 people across its subsidiaries [3] - MediBeacon Inc. specializes in fluorescent tracer agents and transdermal detection technology, holding over 55 granted U.S. patents and more than 250 patents worldwide [4] Product and Technology - The MediBeacon® TGFR™ System includes Lumitrace® (relmapirazin) injection, a reusable sensor, and a monitor, enabling kidney function assessment through transdermal measurement of the clearance rate of the fluorescent agent [7] - Lumitrace® is a non-radioactive, non-iodinated compound designed for GFR tracing, with its fluorescence data collected via a sensor placed on the skin [5] - The TGFR System is approved for human use and is being deployed in key medical centers for applications such as heart failure monitoring and oncology drug dosing [6][2] Clinical Significance - There is a significant clinical need for improved GFR assessment at the point of care, with the transdermal GFR (tGFR) method viewed as a potential game changer in clinical practice [2] - The TGFR System aims to address the limitations of existing GFR assessment methodologies, providing vital measurements of kidney function [2]