The FDA on Thursday approved NorthStar Medical Radioisotopes' RadioGenix System, which produces Technetium-99m — the most common radioisotope used in medical imaging.
The approval will help ensure the U.S. has a secure supply of the chemical agent for medical use, representing the first domestic supply in 30 years. The Nuclear Regulatory Commission is working with the FDA to license the RadioGenix System and enable the Tc-99m to be used for medical purposes.
"This radioisotope is vital to disease detection, yet healthcare professionals have faced challenges with adequate supply due to a complex supply chain that sometimes resulted in shortages,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “Today’s approval … 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."
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