ICUS Files FDA Petitions for Expanded Use of Contrast-Enhanced Ultrasound
The International Contrast Ultrasound Society (ICUS) has filed two Citizen Petitions with the FDA to expand the approved uses of contrast-enhanced ultrasound (CEUS). The first petition requests the approval of a whole-body indication for microbubble ultrasound contrast agents, moving away from the traditional organ-by-organ approval method. The second petition seeks to remove outdated ‘black box’ warnings associated with these agents.
CHICAGO–(BUSINESS WIRE)– #CEUS–The International Contrast Ultrasound Society (ICUS) announced today that it filed two Citizen Petitions with the U.S. Food and Drug Administration (FDA) urging the agency to expand approved uses of contrast-enhanced ultrasound (CEUS) and to modernize its regulation. The first petition calls on the FDA to approve a whole-body indication for approved microbubble ultrasound contrast agents, replacing the traditional organ-by-organ approval approach. The second petition r