Bracco Diagnostics announced today that its Lumason ultrasound contrast agent has received FDA approval for use in enhanced liver ultrasound in both adult and pediatric patients.
The announcement makes Lumason the first ultrasound contrast agent approved for liver imaging, said Alberto Spinazzi, MD, a senior vice president for the Milan-based company.
"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," said Spinazzi. "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."
Previously approved for use in certain cardiac imaging procedures, the contrast agent uses gas-filled microspheres that reflect sound waves to enhance ultrasound images.