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Breakthrough Device Status for MediBeacon’s Transdermal GFR Measurement System
The FDA has designated the Transdermal Glomular Filtration Rate (TGFR) measurement system, manufactured by MediBeacon (St. Louis, Missouri), as a combination product. The TGFR device includes an optical skin sensor, a monitor, and a proprietary fluorescent tracer agent known as MB-102, which glows when light is present. The device will provide continuous real-time GFR measurement in patients with impaired or normal renal function without any need for blood sampling or urine collection.
The ability to measure GFR is critical, particularly in patients who have kidney disease or who are at risk of developing it. Kidney disease, known as a hidden epidemic, affects more than 850 million people worldwide, overshadowing the number of people who are affected by diabetes and cancer.
A press release from MediBeacon noted that tracer agents and devices from the company, including the transdermal GFR measurement system, have not been approved or cleared for human use by any regulatory agency.
Source: Healio.com, October 22, 2018