Bracco Diagnostics said yesterday it won FDA premarket approval for its Lumason ultrasound imaging agent, now indicated for use in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients.
Marketed in other countries as SonoVue, Lumason is a contrast agent made up of gas-filled microbubbles, or microspheres, that reflect sound waves to enhance the image. Lumason was previously approved for use in adults with suboptimal echocardiograms to opacify the left ventricular chamber and improve cardiac imaging.
“Bracco is delighted to obtain FDA approval for the use of Lumason in liver imaging for both adult and 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. We are proud to be the first company to obtain FDA approval for this important clinical use of ultrasound contrast both in adults and children. This new indication for Lumason reflects our efforts and investments to expand the range of approved clinical indications for contrast-enhanced ultrasound in the United States. We are very pleased with the collaborative work with the FDA whose review is critical to ensuring the safety and efficacy of any use of imaging products to the healthcare community,” global medical & regulatory affairs senior veep Dr. Alberto Spinazzi said in a prepared statement.
The Monroe Township, N.J.-based company said the Lumason is the 1st ultrasound contrast agent to win FDA approval for liver imaging to improve the sensitivity and specificity of ultrasonography to differentiate between malignant and benign focal hepatic lesions.
“The expanded indication for Lumason now offers healthcare professionals and their patients further benefits of our ultrasound contrast agent. This approval demonstrates Bracco’s leadership and commitment to the imaging community, across imaging modality 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.,” CEO Vittorio Puppo said in a press release.