FDA approves the first ultrasound contrast agent for liver imaging

The first ultrasound contrast agent intended for use in liver imaging for the characterization of focal liver lesions in adult and pediatric patients has been cleared by the U.S. Food and Drug Administration (FDA). LUMASON, also known as SonoVue®, manufactured by Bracco Diagnostics in Monroe Township, NJ, was approved for use in adults with suboptimal echocardiograms, to opacify the left ventricular chamber and to improve delineation of the left ventricular endocardial border in adult patients.

This contrast agent can also help improve the sensitivity and specificity of ultrasonography for the differentiation between malignant and benign hepatic lesions. This approval also makes LUMASON the first ultrasound contrast agent for use in the pediatric population. It consists of gas-filled microspheres that reflect sound waves to enhance the image in ultrasonography.

The use of contrast-enhanced ultrasound for characterization of focal liver lesions has been in use in several countries in Europe and in Asia. Although this application is newly approved in the United States, the LUMASON contrast agent has been marketed for over 14 years.

In late 2015, the U.S. Centers for Medicare and Medicaid Services granted the contrast agent “pass through” status for reimbursement under the Hospital Outpatient Prospective Payment System. Contrast material is not separately paid by Medicare for outpatient hospitals under OPPS unless the product has a “pass-through” status.