MediBeacon is a medical technology company specializing in the advances of fluorescent tracer agents and transdermal measurement. The science is complex, but the outcomes are simple to understand. How it works >>
The MediBeacon Transdermal GFR Measurement System (TGFR) is engineered to allow non-invasive detection of the change in patient levels of a fluorescent GFR tracer agent over time via a sensor placed on the patient’s skin. The rate of decrease in the emitted fluorescence from Lumitrace®, a nonradioactive, non-iodinated fluorescent tracer agent, is automatically calculated and displayed on the monitor and is intended to provide information regarding the rate of clearance of Lumitrace injection which may be useful in the understanding of kidney function in real-time. The TGFR Monitor displays this information in the form of a transdermal GFR (tGFR).
The Medibeacon Transdermal GFR Measurement System (TGFR) has been designed to measure tGFR across the full range of human skin colors as quantified by the Fitzpatrick Skin Prototype (FSP). The FSP classifies human skin colors into six broad categories.
1 Australian Government – ARPANSA
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The Medibeacon TGFR proposed indications for use include the measurement of Glomerular Filtration Rate (GFR) in patients with impaired or normal renal function. Better tools for the management of kidney patients are needed. Consistent with this FDA granted the TGFR a Breakthrough Device Designation in recognition that the technology has the potential to provide for more effective patient management. Subsequent to an eventual regulatory approval any improvement in the standard of care would need to be demonstrated in the clinic. The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of lifethreatening or irreversibly debilitating diseases or conditions. More >>