MALLINCKRODT/MBI's FS069 PMA FOR ECHOCARDIOGRAPHY CLEARS FDA RADIOLOGICAL DEVICES ADVISORY PANEL; AGENCY ON TARGET TO MEET 180-DAY REVIEW DEADLINE
Executive Summary
FDA's Radiological Devices Panel voted six to one to recommend approval of Molecular Biosystems' FS069 second-generation echocardiogram ultrasound contrast agent Feb. 24. FDA staffers say the agency is on target to meet its six-month deadline for a final decision on the PMA, which was submitted in October.