NorthStar Medical Radioisotopes has received U.S. Food and Drug Administration (FDA) approval to manufacture its RadioGenix isotope separation system at the firm's headquarters facility in Beloit, WI. It has also formally launched the system, which can produce technetium-99m from nonuranium-based molybdenum-99.
With the new FDA approval for manufacturing RadioGenix and associated materials, NorthStar can expand its RadioGenix manufacturing volume fourfold, according to President and Chief Operating Officer Stephen Merrick. NorthStar has signed its first customer contract for RadioGenix and scheduled installation.
Additional system shipments are anticipated as potential customers receive licensing amendments for their sites, according to the company.
