Shots:
- The US FDA has approved MediBeacon TGFR to assess patients with normal or impaired renal function
- The system met FDA-approved 1EP of 94% P30 value (% of GFR estimates within ±30% of mGFR) in patients with varied GFR & skin tones. The approval aligns with recent data publication in support of Lumitrace in Kidney International (Q4’24)
- The system includes a TGFR Sensor & Monitor, plus a Lumitrace injection (relmapirazin; fluorescent GFR tracer) to measure renal function by tracking its clearance transdermally via the sensor, providing real-time tGFR readings at 2.5 readings/sec at bedside or OPD
Ref: Globenewswire | Image: Innovate
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