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FDA Approves Label Changes for Optison

The International Contrast Ultrasound Society (ICUS)

FDA Approves Label Changes for Optison

The FDA has approved label changes for GE Healthcare's ultrasound contrast agent Optison, removing contraindications for use in patients with cardiac shunts and for administration by intra-arterial injection. Optison is the 1st contrast agent available in the U.S. to receive this label change, according to GE.

ICUS Co-President, Dr. Steven Feinstein commented:  “Up to one-third of our patients have known or suspected cardiac shunts and, thanks to this important FDA decision, they too will now have access to ultrasound contrast agents, which offer an inexpensive and radiation-free option for diagnostic imaging.”  He added,  “The International Contrast Ultrasound Society applauds the FDA for its decision, and believes it will benefit individual patients as well as our healthcare delivery system.”

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