FDA grants breakthrough device status to MediBeacon

MediBeacon (St. Louis) recently announced that it has won FDA breakthrough device designation for its Transdermal GFR Measurement System (TGFR).

TGFR is one of several products granted breakthrough status, FDA’s expedited path outlined in the 21^st Century Cures Act. The product measures glomerular filtration rates (GFRs) in patients with impaired or normal renal function.

TGFR is considered a combination product and includes an optical skin sensor, monitor and MB-102, a proprietary fluorescent tracer agent that glows in the presence of light. The device is designed to provide clinicians continuous real-time measurement of GFR at the point of care with no need for blood sampling or urine collection.

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