ICUS Urges Removal of Boxed Warnings

ICUS is awaiting a decision on its Citizen Petition urging the FDA to remove “boxed warnings” on ultrasound contrast agents.

The ICUS petition cites a favorable risk-benefit profile, supported by new scientific studies demonstrating safety and efficacy. ICUS also cites precedent for reversal of “black boxes” when new data show that risks are less severe than previously thought.

The ICUS Citizen Petition is supported by statements filed by other ultrasound professional societies and CEUS experts.