MediBeacon® Transdermal GFR Measurement System (TGFR)
FDA premarket approval P230019 · decided 2025-01-17
Approval details
- PMA number
- P230019
- Trade name
- MediBeacon® Transdermal GFR Measurement System (TGFR)
- Generic name
- Transdermal test for Assessment of Glomerular Filtration Rate
- Applicant
- Medibeacon, Inc.
- Date received
- 2023-06-20
- Decision date
- 2025-01-17
- Days to decision
- 577 days
- Decision code
- APPR
- Product code
- SDK
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- St. Louis, MO
- Statement
- Approval for the MediBeacon® Transdermal GFR System (TGFR) intended to assess the Glomerular Filtration Rate (GFR) in adult patients with impaired or normal renal function by noninvasively monitoring fluorescent light emission from an exogenous tracer agent over time. This device has been validated in patients with stable renal function.The MediBeacon® TGFR is not approved for use in patients with GFR <15 ml/min/1.73 m2, GFR >120 ml/min/1.73m2, patients on dialysis, or anuric patients. The use o
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