MediBeacon TGFR System Earns FDA Approval for Revolutionary Kidney Function Assessment

The U.S. Food and Drug Administration (FDA) has approved the MediBeacon® Transdermal Glomerular Filtration Rate (TGFR) System, a first-of-its-kind device for assessing kidney function in patients with both normal and impaired renal function. Developed by INNOVATE Corp. (NYSE: VATE), this innovative system aims to transform diagnostics for chronic kidney disease (CKD), a condition affecting over 800 million people globally.

The TGFR System combines advanced technology, including a TGFR Sensor, TGFR Monitor, and Lumitrace® (relmapirazin) injection, to measure kidney function without the need for blood draws or urine analysis. Instead, the device uses a non-radioactive, fluorescent tracer agent, recording its clearance rate through the skin via a sensor. With 2.5 fluorescent readings per second, the system provides real-time results at the patient’s bedside or in outpatient settings.

This approval marks a milestone in nephrology, eliminating reliance on estimating equations and laboratory testing for Glomerular Filtration Rate (GFR) assessments. “This system offers an essential advancement for patients whose kidney function assessment remains suboptimal under current methodologies,” said Dr. Mitchell Rosner of the University of Virginia.

MediBeacon CEO Steve Hanley highlighted the system’s importance in addressing CKD, a condition causing more annual deaths than breast or prostate cancer. The TGFR is expected to see widespread application, bridging gaps in kidney diagnostics and potentially improving patient outcomes in clinical and outpatient environments worldwide.

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