The US FDA Approves Innovate’s MediBeacon Transdermal GFR System to Evaluate Renal Function
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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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
