Research & Development
MediBeacon TGFR receives US FDA approval
20 January 2025 -

US-based medical technology company specialising in the advancement of fluorescent tracer agents and their transdermal detection MediBeacon Inc. announced on Friday FDA approval of the MediBeacon TGFR system for assessing kidney function in patients with normal or impaired renal function.

The TGFR system includes the TGFR Sensor, TGFR Monitor and Lumitrace (relmapirazin) injection, a non-radioactive, non-iodinated fluorescent tracer agent. Lumitrace clearance is measured transdermally through a skin sensor, with 2.5 readings per second recorded and displayed at the point of care. The system provides Glomerular Filtration Rate (GFR) assessments without the need for blood draws, urine samples, or offsite laboratory analysis.

Current clinical practices for measured GFR require sophisticated laboratory processing, which the TGFR eliminates. This advancement enables more efficient and patient-friendly kidney function assessment.

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