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

Share this content:
FDA Says U.S. Will Now Produce Critical MRI Component
FDA Says U.S. Will Now Produce Critical MRI Component

THURSDAY, Feb. 8, 2018 (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.

"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.

More Information

Share this content:

is free, fast, and customized just for you!




Already a member?

Sign In Now »

Trending Activities

All Professions

Drug Lookup

Browse drugs by: BrandGenericDisease

More in Home

FDA Permits Marketing of Brain Stimulation Device for OCD

FDA Permits Marketing of Brain Stimulation Device for ...

FDA previously approved transcranial magnetic stimulation for major depression, certain migraines

Comments Open on End of NIH Review for Gene Therapy Studies

Comments Open on End of NIH Review for ...

NIH oversight panel no longer plans to review all applications for gene therapy experiments

U.S. Measles Outbreak Hits 107 Cases in 21 States, D.C.

U.S. Measles Outbreak Hits 107 Cases in 21 ...

Outbreak on track to exceed last year's; most of the people who got measles weren't vaccinated

is free, fast, and customized just for you!




Already a member?

Sign In Now »