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The RadioGenix is also a platform technology that has the potential ability to apply its separation capabilities at the point-of-care to other radioisotopes in the future, including therapeutic isotopes such as actinium-225/bismuth-213 (which will require FDA approval). Bringing RadioGenix successfully to the U.S. Pharmacopeia (USP) Sodium Pertechnetate Tc 99m Injection from Mo-99.
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healthcare system’s reliance on fragile foreign supply of Mo-99 and the use of enriched uranium target material. The RadioGenix System allows for automated, on-site separation and preparation of U.S. The approval by the FDA will reduce the U.S. producer of Mo-99 in more than 25 years, we are extremely proud to pioneer domestic production of Mo-99 that is independent of uranium-based product.
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“As the first, and thus far only company to achieve the objective of being the first U.S. Messina, Chairman and CEO of NorthStar Medical Radioisotopes. “With the FDA’s approval of the RadioGenix System, NorthStar can begin providing its customers with a reliable and environmentally friendly supply of the Mo-99 radioisotope for the United States,” said George P. Furthermore, current bulk production of Mo-99 is based on enriched uranium which poses significant environmental concerns. The supply of Mo-99 has been subject to frequent and sometimes prolonged interruptions, disrupting and often delaying the diagnosis and treatment of patients in need of medically important diagnostic tests that require the use of this radioisotope. production of Mo-99, the parent isotope of Tc-99m, for more than 25 years.
#Technetium 99 m generator generator
The RadioGenix TM System is indicated as “a technetium Tc 99m generator used to produce sterile, non-pyrogenic Sodium Pertechnetate Tc 99m Injection.” Food and Drug Administration (FDA) has approved the RadioGenix TM System, an innovative, high tech radioisotope separation platform indicated for use in producing the widely used medical radioisotope technetium-99 (Tc-99m) from NorthStar’s non-uranium based molybdenum-99 (Mo-99). – February 8, 2018 – NorthStar Medical Radioisotopes, LLC, (NorthStar) a company involved in the production and distribution of radioisotopes used for medical imaging, today announced that the U.S. source of medical radioisotope Mo-99 in more than 25 years –īELOIT, Wis. – Enables domestic Mo-99 supply produced without uranium for U.S.