GE Healthcare announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to manufacture Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) in-house. Optison is a contrast agent that may improve the visualization of the left ventricular border ? an area of the heart that is critical to see in order to assess and diagnose certain heart diseases. As a result of the FDA’s action, GE Healthcare will provide a supply of Optison to the U.S. and European markets from its manufacturing facility in Oslo, Norway, becoming the only contrast media manufacturer to supply its own stock to the United States.
