Nuclear Regulatory Commission hopes new FDA-cleared system will ensure stable supply of technetium-99m for nuclear imaging – The U.S. Food and Drug Administration (FDA) and the Nuclear Regulatory Commission (NRC) recently took steps to ensure a stable and secure supply of a critical radioactive imaging tracer used to detect potentially life-threatening diseases.
The FDA approved the NorthStar Medical Radioisotopes’ RadioGenix System, a unique system for producing the medical radioisotope molybdenum-99 (Mo-99), the precurser to the making technetium-99m (Tc-99m), the most widely used radioisotope in medical imaging. The NRC is issuing guidance and will license the RadioGenix System to enable the Tc-99m it produces to be used for medical imaging.
“I’m proud to acknowledge the role the FDA played in the groundbreaking effort to develop a new imaging technology,” said FDA Commissioner Scott Gottlieb, M.D. “This new technology was the result of a broad collaboration across the federal government and industry, and has the potential to benefit many patients as well as restore the U.S. ability to domestically supply a critical medical diagnostic tool for the first time in 30 years.”
Dave Fornell – Imaging Technology News – February 8, 2018.
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