Medical imaging isotopes are used to diagnose various diseases, such as cancer and coronary artery disease, and to evaluate brain, lung, kidney, and liver function. According to an U.S. Food and Drug Administration (FDA) press release, the most widely used medical imaging isotope, Technetium-99m (Tc-99m), is used in over 80% of the United States’ nuclear medical imaging procedures. Used in conjunction with certain diagnostic scanner devices, Tc-99m transmits signals which are used to generate images of organs. This information assists medical professionals in detecting medical issues and making decisions related to diagnosis and treatment.

According to Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, “[e]very day, tens of thousands of people in the U.S. undergo a nuclear medical imaging procedure that depends on Tc-99m.” However, according to the FDA press release, for thirty years, the U.S. has relied on other countries for its supply of Molybdenum-99 (Mo-99), the source of Tc-99m. As part of that process, the U.S. has been exporting highly enriched uranium. As a result of the complex supply chain, the U.S. has encountered challenges such as high costs and shortages of the isotope. Supply chain issues have also caused many medical professionals to opt to use different isotopes, which can mean higher doses of radiation or even higher costs.

To try to remedy some of these issues, Congress enacted the American Medical Isotopes Production Act in 2012. According to the FDA press release, the act required evaluation of and support for projects related to the domestic production of Mo-99 for medical purposes, without the use of highly enriched uranium.

The FDA press release notes that the U.S. Food and Drug Administration (FDA) has now approved NorthStar Medical Radioisotopes’ RadioGenix System, which is the first system for producing Tc-99m that uses non-uranium based Mo-99. According to Dr. Woodcock, the FDA’s approval of this system “will help to ensure more reliable, clean and secure access to this important imaging agent…”

According to a statement by FDA Commissioner Scott Gottlieb, M.D.,

while we needed to preserve the availability of Tc-99m for its important medical purpose, it was critical that we find a more stable, secure and sustainable technology for production.

Moving forward, according to the FDA announcement, the Nuclear Regulatory Commission is “issuing guidance that will advise medical and commercial nuclear pharmacy users on the license amendments they will need to possess and use the RadioGenix System.”