US FDA | Strategic move to produce Tc-99m for medical imaging procedures

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, or 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.

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