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.

Image result for radiogenix

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.

Image result for radioisotope imaging

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.

Robert Hilton
Dr. Robert J. Hilton focuses primarily on patent prosecution in the chemistry and life sciences fields. Robert assists a wide range of clients, including small and large companies locally and internationally. He currently represents clients with technology in the fields of stem cells, CAR T cells, prostate cancer therapeutics and other oncology pharmaceuticals, vaccines, medical devices, dietary supplements, diagnostic devices and assays, cosmetics, and therapeutic antibodies. Robert earned his Ph.D. in biochemistry from BYU. His research involved the studies of metals in biological systems, including metal dysregulation in diseases such as chronic kidney disease.
Click here to read full bio
View all posts published by Robert Hilton »

Leave a Reply

By using this blog, you agree and understand that no information is being provided in the context of any attorney-client relationship. You further agree and understand that nothing herein is intended to be legal advice. This blog is solely informational in nature, and is not intended as, and should not be used as, a substitute for competent legal advice from a retained and licensed attorney in your state. Knobbe Martens LLP makes no representations or warranties as to the accuracy, completeness, timeliness or availability of the information in this blog. Knobbe Martens LLP will not be liable for any injury or damages relating to your use of, or access to, any such information. Knobbe Martens LLP undertakes no obligation to correct or update information on this blog, which may be incorrect or become incorrect or out of date over time. Knobbe Martens LLP reserves the right to alter or delete content or information on the blog at any time. This blog contains links and references to other websites and publications that you may find of interest. Knobbe Martens LLP does not control, promote, endorse or otherwise have any affiliation with any other websites or publications unless those websites or publications expressly state such an affiliation. Knobbe Martens LLP further has no responsibility for, and makes no representations regarding, the content, accuracy or any other aspect of the information in such websites or publications.