MediBeacon has received the CE Mark certification under the European Union (EU) Medical Device Regulation (MDR) for its transdermal glomerular filtration rate (TGFR) monitor and reusable sensor.
The two Class IIa devices, alongside the Lumitrace (relmapirazin) injection and TGFR disposable ring, form the TGFR system.
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The certification confirms compliance with EU MDR 2017/745 safety, quality, and performance standards.
The TGFR system assesses kidney function by measuring the clearance of a fluorescent agent.
Lumitrace is currently approved in China and the US, with submission to EU regulatory authorities pending.
The TGFR system is approved for human use by the US Food and Drug Administration (FDA) and the China National Medical Products Administration (NMPA).
The technology is undergoing additional clinical development for applications in gastroenterology, ophthalmology, and surgery.
Relmapirazin is an inert, highly fluorescent pyrazine-based compound engineered as a GFR tracer agent. Its photophysical properties enable fluorescence data collection via a skin-placed photodetector sensor.
MediBeacon co-founder and CEO Steven Hanley said: “Obtaining the EU CE Mark is a significant milestone for MediBeacon.
“As the TGFR System enters the clinic in the US and China, the CE Mark allows for the potential use of the transdermal technology in clinical trials that include European sites. The achievement also underscores our commitment to meeting the highest quality and safety standards.”
The company owns over 55 granted patents in the US and more than 250 worldwide related to its sensor technologies, algorithms, fluorescent tracer agents, and other pyrazine platform uses.
In January 2025, the FDA granted approval to the MediBeacon TGFR system for evaluating kidney function in individuals with normal or impaired renal function.
