Centers of Excellence commercialization in select academic medical centers begins in early 2026
INNOVATE Corp. that MediBeacon Inc. , a medical technology company specializing in the advancement of fluorescent tracer agents and their transdermal detection, in which INNOVATE owns a 44.7% equity interest, has received approval from the U.S. Food and Drug Administration (FDA) for the next generation MediBeacon TGFR System including the latest TGFR Reusable Sensor.
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The TGFR System enables kidney function assessment at the point of care by measuring the clearance rate of Lumitrace (relmapirazin), a non-radioactive, non-iodinated fluorescent GFR agent. The TGFR Reusable Sensor placed on the skin measures the change in Lumitrace fluorescence intensity as a function of time.
The latest TGFR Reusable Sensor has been designed for patient comfort, ease of application, and reusability. It also lowers the cost compared to the single use TGFR Sensor previously approved by the FDA.
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The TGFR System was the subject of the lead peer-reviewed article featured on the cover of the Journal of the American Society of Nephrology (JASN) in August 2025. The article reviewed the first use of the transdermal GFR (tGFR) methodology in patients of various levels of kidney function across a wide range of skin colors.
MediBeacon will offer early access for specific use cases at leading academic medical centers in the United States and China. Many of these medical centers have used MediBeacon’s transdermal GFR technology in preclinical research over the past 10 years. There are over 700 peer-reviewed publications and conference abstracts on preclinical use in which the tGFR methodology has been utilized.
“We look forward to including transdermal GFR in our ongoing heart failure study where renal function is a valuable consideration in patient monitoring,” said Dr. Melana Yuzefpolskaya, cardiologist at New York Presbyterian Hospital-Columbia. “Validating transdermal GFR in this patient population offers the opportunity to expose clinically meaningful inaccuracies in estimated GFR (eGFR).”
The TGFR Reusable Sensor is validated for reuse via connection to a disposable adhesive ring. Transdermal assessment of Glomerular Filtration Rate or kidney function (tGFR) has been designed to be effective across the adult population without input of age, weight, sex, gender, race, or ethnicity. MediBeacon received FDA approval of an earlier TGFR System version in January 2025.
“This approval is a major step for MediBeacon to achieve its goal to improve kidney health”, said Steven Hanley, CEO and Co-Founder of MediBeacon. “With this approval, we have a comprehensive, sustainable and economic technology solution to assess kidney function. We believe MediBeacon is well positioned to scale with discipline and unlock the significant market opportunity ahead in both inpatient and outpatient settings.”
MediBeacon expects to begin initial sales of the TGFR System to select academic medical centers in the first quarter of 2026 in the United States and China.
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Source- GlobeNewswire
