Enforcement Report - Week of November 30, 2022
LUMASON, known globally as SonoVue®, which has been marketed since 2001 and now in more than 30 countries, was initially approved in October 2014 by the FDA for use in adults with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. LUMASON then gained FDA approval in March 2016 for use in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients, and in December 2016, for use for the evaluation of suspected or known vesicoureteral reflux in pediatric patients.
Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., one of the world's leading companies in the diagnostic imaging business, announced today that LUMASON is now approved for use in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients.