FDA, NRC approves RadioGenix medical isotope production from NorthStar Medical Radioisotopes

The FDA and Nuclear Regulatory Commission today approved NorthStar Medical Radioisotopes‘ RadioGenix system designed to produce Technetium-99m, which it said is the most widely used radioisotope in medical imaging. Guidance from the NRC, an independent agency created by congress to license and regulate the civilian use of radioactive materials, was issued to allow the system to produce the Tc-99m for medical purposes. With the guidance, the RadioGenix system is cleared to produce sodium pertechnetate Tc-99m to be injected intravenously, instilled into the bladder or eye or used with other FDA approved imaging drugs, the NRC said. The RadioGenix system was created through a collaboration between the federal government and the industry. “Every day, tens of thousands of people in the U.S. undergo a nuclear medical imaging procedure that depends on Tc-99m. 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,” FDA Center for Drug Evaluation and Research director Dr. Janet Woodcock said in a press rel...
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Imaging Regulatory/Compliance northstarmedicalradioisotopes Source Type: news