MediBeacon Nabs FDA Approval for TGFR System to Assess Kidney Function

Medical technology company MediBeacon has won FDA approval for its Transdermal GFR (TGFR) system for evaluating kidney function in individuals with normal or impaired renal function.

The first-of-its-kind product includes a TGFR sensor, TGFR monitor, and Lumitrace (relmapirazin) injection, a nonradioactive, noniodinated fluorescent glomerular filtration rate (GFR) tracer agent. Together, these components allow assessment of kidney function by measuring the clearance rate of the fluorescent agent as it leaves the body.

Placed on the skin, the sensor measures Lumitrace fluorescence intensity transdermally, recording 2.5 fluorescent readings per second. The monitor displays the average session TGFR reading at a patient’s bedside or in an outpatient setting. Unlike current methodologies, the TGFR system does not require blood draws or urinalysis, nor does it require sophisticated clinical laboratory analysis away from the point of care.

The product is validated for use in the assessment of GFR in patients with stable kidney function at the point of care. In addition, data from a recent study by MediBeacon’s chief scientific officer, Richard Dorshow, PhD, and others support the use of Lumitrace as a GFR tracer agent.

Source: Press release