FDA Approves Technology to Produce Substance Critical to Cardiac Imaging

The U.S. Food and Drug Administration (FDA) has approved a new technology to produce the radioisotope Technetium-99m (Tc-99m), a substance that plays a critical role in a wide range of routine medical imaging procedures, including cardiac imaging, in the U.S., per a Feb. 8 statement from FDA Commissioner Scott Gottlieb, MD.

The approval of the technology, known as the RadioGenix System, calms concerns of a long-feared Tc-99m shortage. Prior to approval, the Tc-99m production process involved shipping enriched uranium out of the U.S. for irradiation. Tc-99m has a limited shelf life, so a stable supply chain is critical for maintenance. Previously, all reactors that produced this source material were located outside of the U.S., creating a complicated and uncertain supply chain.

"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," said Gottlieb.

Clinical Topics: Noninvasive Imaging

Keywords: ACC Advocacy, United States, Technetium, Uranium, United States Food and Drug Administration, Radioisotopes, Uncertainty, Security Measures, Diagnostic Imaging

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