FDA clears Nycomed contrast injector
Nycomed Amersham may be planning to bring a CT contrast injector system to market. Food and Drug Administration records indicate that the agency on Feb. 19 granted 510(k) clearance to the Anglo-Norwegian company for a device called Premica, listed as a
Nycomed Amersham may be planning to bring a CT contrast injector system to market. Food and Drug Administration records indicate that the agency on Feb. 19 granted 510(k) clearance to the Anglo-Norwegian company for a device called Premica, listed as a CT contrast media delivery system.
If Nycomed Amersham does bring such a product to market, it would compete with contrast injectors from companies owned by two of Nycomed's competitors in the contrast business, Schering and Mallinckrodt. Schering owns Medrad of Indianola, PA, while Mallinckrodt owns St. Louis-based Liebel-Flarsheim. Nycomed does not currently market a contrast delivery system.