February 9, 2018

FDA: New imaging technology promises stable supply of imaging isotope

By: Judy Mathias

Editor’s Note

The Food & Drug Administration (FDA) Commissioner, Scott Gottlieb, MD, on February 8 announced the role the FDA played in the groundbreaking effort to develop a new imaging technology−the RadioGenix System.

The technology, which resulted from a collaboration across the federal government and industry, has the potential to benefit many patients and restore the ability of the US to supply a critical medical diagnostic tool for the first time in 30 years, Gottlieb says.

The RadioGenix System is a manufacturing system for producing radioisotope Technetium-99m (Tc-99m), which plays a vital role in nuclear imaging studies for a wide range of uses, including cancer and cardiology.

Previously, the production process for Tc-99m involved shipping enriched uranium out of the US for irradiation. All of the reactors that produced this source material were located outside the US. 


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