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.
Organon acquires US rights to TOFIDENCE from Biogen
Oncopeptides secures FDA approval to resume OPD5 clinical development
Bonesupport submits FDA application for CERAMENT V
Spinogenix starts enrolment for SPG302 Phase 2 trial in schizophrenia
DDL opens new GMP laboratory for drug-device combination product testing
Langhua Pharmaceutical passes US FDA's on-site inspection
PTC Therapeutics announces opinion regarding Translarna's (ataluren) European renewal authorisation
Soleno Therapeutics selects PANTHERx Rare as specialty pharmacy for VYKAT XR distribution