FDA Says U.S. Will Now Produce Critical MRI Component

From Drugs.com - February 8, 2018

FDA Says U.S. Will Now Produce Critical MRI Component

THURSDAY, Feb. 8, 2018 -- 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 substance -- a radioisotope called Technetium-99m (Tc-99m). The newly approved technology is known as the RadioGenix System.

The radioisotope plays a crucial role in nuclear imaging studies for a wide range of uses, including cancer and cardiology. It's used in more than 80 percent of routine medical imaging procedures on about 50,000 Americans every day, according to the FDA.

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 Dr. Scott Gottlieb 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 also "may expose patients to higher doses of radiation," Gottlieb said.


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