Bracco announced today that the FDA has given clearance to the contrast agent LUMASON for use in liver ultrasound for characterization of focal liver lesions. The agent — known globally as SonoVue — is also now the first ultrasound contrast agent approved in the U.S. for use in pediatric patients.

"The use of contrast-enhanced ultrasound for characterization of focal liver lesions is already established in several countries in Europe and Asia, and Bracco is glad to offer this diagnostic option to U.S. patients," said Fulvio Renoldi Bracco, Head of Global Business Unit Imaging at Bracco Imaging, in a statement.

LUMASON had already been cleared 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 in adult patients. That approval took place in October 2014.
The agent has been marketed for over 14 years in more than 40 countries. It is made up of gas-filled microspheres that reflect sound waves to enhance ultrasound images.

"The expanded indication for LUMASON now offers health care professionals and their patients further benefits of our ultrasound contrast agent," said Vittorio Puppo, CEO and president of Bracco Diagnostics, in the release. "This approval demonstrates Bracco's leadership and commitment to the imaging community, across imaging modality and service lines. We are proud to be a leader in contrast imaging and delivery systems, and of our continuous investment in imaging activities to help improve patient care in the U.S."

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