FDA Approves NorthStar’s Tc-99m Generator

The Food and Drug Administration recently announced approval of the RadioGenix™ System, a technetium 99m (Tc-99m) generator. The RadioGenix™ System is developed by NorthStar Medical Radioisotopes, LLC, a nuclear medicine technology company.  

According to the press release, Tc-99m is a diagnostic agent used in more than 40,000 imaging procedures daily for diagnosis and treatment of patients. Prior to approval of the RadioGenix™ System, Tc-99m could only be produced from enriched uranium in facilities outside of the United States that relied on a complicated and potentially unreliable supply of stable uranium radioisotopes. The development of the RadioGenix™ System alleviates these vulnerabilities by providing a reliable domestic source of Tc-99m.

According to Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research,
This radioisotope is vital to disease detection, yet health care professionals have faced challenges with adequate supply due to a complex supply chain that sometimes resulted in shortages. Today’s approval has been the result of years of coordination across the FDA and with U.S. government organizations and marks the first domestic supply of Mo-99 – the source of Tc-99m –  in 30 years, which will help to ensure more reliable, clean and secure access to this important imaging agent used in nuclear medicine.

According to NorthStar, the RadioGenix™ System is the first and only device for producing a non- uranium Tc-99m.  Rather than uranium, the system uses molybdenite, a naturally occurring molybdenum found in the earth’s crust, as the starting material. Major applications of Tc-99m include detection of potential diseases like coronary artery disease and cancer, as well as evaluating lung, liver, kidney, and brain function. 

Written by Robert Hilton