The International Contrast Ultrasound Society (ICUS)

ICUS Pleased by FDA Modification of Boxed Warnings on Additional Ultrasound Contrast Agents

WASHINGTON, DC -- The International Contrast Ultrasound Society (ICUS) today applauded the FDA’s
decision to modify the U.S. product label for OPTISON®, an ultrasound contrast agent used to improve
the accuracy of radiation-free ultrasound scans. OPTISON® is marketed by GE Healthcare.

The label change was supported by a Citizen Petition filed by ICUS in October, citing newer scientific
studies showing the superior safety profile of ultrasound contrast agents along with their favorable risk-
benefit ratios. The Citizen Petition, which was granted in part by the FDA last week, also supported
a prior modification of the label for DEFINITY®, an ultrasound contrast agent marketed by Lantheus
Medical Imaging.

Please click on the attachment below to read the complete press release

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ICUS is the world’s only professional society exclusively devoted to contrast-enhanced ultrasound (CEUS) medical imaging technology.

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