The International Contrast Ultrasound Society (ICUS)

GE Healthcare Receives Approval for Its Own Manufacturing of Optison™

On November 18, 2013, GE Healthcare announced that it received approval from the U.S. Food and Drug Administration (FDA) to allow the company 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 US and European markets from its manufacturing facility in Oslo, Norway, becoming the only contrast media manufacturer to supply its own stock to the US.
 
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