The FDA and Nuclear Regulatory Commission approved the RadioGenix system, which will allow the first domestic production of the medical imaging isotope Technetium-99m in 25 years.
Here are seven things to know:
1. The RadioGenix system is a unique system for producing Technetium-99m, the most widely used radioisotope in medical imaging. According to CNBC, Tc-99m is used in 40,000 procedures a day in the U.S., the world's top consumer of radioisotopes for medical imaging to help detect cancer and heart problems.
2. Before Feb. 9, U.S. consumers had to rely on a risky supply chain for the materials which involved shipping weapons-grade uranium from the U.S. to research reactors in Australia, South Africa and Europe where it is irradiated to make Molybdenum-99, which decays into Tc-99m, according to CNBC. This process left the U.S. vulnerable to possible shortages and supply chain issues.
3. Congress enacted the American Medical Isotopes Production Act of 2012, which contained provisions to eliminate the use of highly enriched uranium for medical isotope production and encouraged the development of domestic Mo-99 and associated isotopes. The FDA and other federal agencies have been collaborating with industry to develop a technology to minimize dependence on highly enriched uranium and bring the supply chain within the U.S.
4. The United States has suffered shortages of imaging isotopes in the past; the most severe shortage occurred in 2010. The risk of shortages increased in 2016 when Canada shut a research reactor.
5. The RadioGenix System enables the American medical community to have a domestic source of Tc-99m through the first non-uranium process for the production of Mo-99.
6. The FDA approved the RadioGenix System to produce sodium pertechnetate Tc-99m injection for intravenous injection, instilled into the bladder, eye, or used with other FDA-approved imaging drugs to examine specific tissues and organs. The injection will contribute to cumulative radiation exposure, so healthcare workers should take recommended precautions to protect against unintentional exposure.
7. The approval of RadioGenix System was granted to NorthStar Medical Radioisotopes. According to CNBC, NorthStar expects to have the ability to supply around 10 percent of the U.S. market by late 2019, and will ramp up production capacity over the next few years to meet two-thirds of U.S. demand.
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