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FDA Okays Non-Uranium Medical Imaging Isotope System

February 08, 2018
FDA, working with the Nuclear Regulatory Commission, approved NorthStar Medical Radioisotopes' RadioGenix System, a “novel manufacturing system” to produce a non-uranium version of radioisotope technetium-99m (Tc-99m), a diagnostic agent used in nuclear imaging studies to detect cancer and coronary artery disease, FDA and Commissioner Scott Gottlieb announced in simultaneous press statements on Thursday (Feb. 8). Tc-99m, used in more than 80 percent of nuclear medicine imaging procedures in the United States, is derived from molybdenum-99 (Mo-99) and up to now...


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