FDA approves Lumason for hepatic lesions in adults, children

The FDA has approved Lumason for use in ultrasonography of the liver to differentiate between hepatic lesions in adult and pediatric patients, according to a press release from the manufacturer.

Lumason (sulfur hexafluoride lipid-type A microspheres, Bracco Diagnostics), a contrast agent comprised of gas-filled microspheres that reflect sound waves to enhance an image, will improve the sensitivity and specificity of ultrasonography to better differentiate between malignant and benign focal hepatic lesions. It is the first approved ultrasound contrast agent for children, according to the release.

“Bracco is delighted to obtain FDA approval for the use of Lumason in liver imaging for both adult and pediatric patients,” Fulvio Renoldi Bracco, head of global business unit imaging at

Bracco Imaging, said in the release. “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.”

The FDA first approved Lumason in 2014 for use in echocardiograms of patients whose ultrasound image of the heart were too difficult to see with ultrasound waves.

Lumason should only be used for ultrasonography of the liver for liver lesions and in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult patients with suboptimal echocardiograms, according to the release.

Contraindications for use mentioned in the release include: known or suspected right-to-left, bi-directional or transient right-to-left cardiac shunts, and history of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients.

Disclosure: Bracco is employed by Bracco Diagnostics.