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Medical Devices / Submissions and Approvals

FDA Approves RadioGenix System for Key Medical Isotope in Diagnostic Imaging

Feb. 12, 2018

NorthStar Medical Radioisotopes received FDA approval for its RadioGenix System indicated for use in producing a medical radioisotope imaging product called technetium-99m.

The Tc-99m diagnostic agent is “the most widely used radioisotope in medical imaging,” according to the FDA. It is intended to aid clinicians in diagnosing ailments, such as coronary artery disease and cancer, by producing images of internal organs and evaluating their function.

“This new technology was the result of a broad collaboration across the federal government and industry, and has the potential to benefit many patients as well as restore the U.S. ability to domestically supply a critical medical diagnostic tool for the first time in 30 years,” FDA Commissioner Scott Gottlieb said in a statement. “It is used in more than 80 percent of routine medical imaging procedures relied on by some 50,000 Americans every day. Because the imaging agent has a limited shelf life, a stable supply chain is critical.”

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