GE Healthcare (NYSE:GE) said it received pre-market approval from the FDA to begin in-house manufacturing of its Optison imaging agent.
Optison (or Perflutren Protein-Type A Microspheres Injectable Suspension) is a contrast agent designed to improve visualization of the heart’s left ventricle.
GE Healthcare said it can now supply the contrast agent to the U.S. and Europe from its manufacturing facility in Oslo, Norway, making it the only contrast media manufacturer to supply its own stock to the U.S. market.
"Adding our own manufacturing site for Optison has multiple benefits for physicians and patients, including an ability to increase capacity to meet market demands and help to ensure consistent supply to the contrast media market. GE Healthcare is committed to providing safe, reliable, innovative and effective diagnostic products that aid in the detection of cardiovascular diseases," core imaging general manager Jan Makela said in prepared remarks.
Earlier this week GE Healthcare revealed plans to sell its Vital Signs medical consumables business to CareFusion (NYSE:CFN) for $500 million.