FDA: 'Groundbreaking' Approval Enables Domestic Supply of Critical Medical Isotope

The RadioGenix System is a novel manufacturing system for producing radioisotope Technetium-99m
The RadioGenix System is a novel manufacturing system for producing radioisotope Technetium-99m

(HealthDay News) — A long-feared shortage of a substance used in millions of medical imaging procedures each year in the United States appears to have been avoided, federal officials report.

The U.S. Food and Drug Administration announced today that it has approved a new technology to produce the country's own supply of the radioisotope Technetium-99m (Tc-99m). The newly approved technology is known as the RadioGenix System.

The imaging agent has a limited shelf life, so a stable supply chain is critical, the FDA said. Until now, however, "the production process for Tc-99m involved shipping enriched uranium out of the U.S. for irradiation," FDA Commissioner Scott Gottlieb, M.D., said in an agency news release. That's because all reactors that produced Tc-99m were in other countries, "creating a complicated, at times uncertain and potentially risky supply chain" that also was costly, he said. Frequent disruptions in the supply chain forced U.S. health care providers to shift to using more expensive isotopes that could also expose patients to higher doses of radiation.

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"The system we've approved today will not only help save and improve the lives of patients, but will reduce the risk of drug shortages and strengthen our national security by creating a U.S.-based manufacturing capacity that is less vulnerable to supply disruptions," Gottlieb said.

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