Bracco Imaging has announced that VueJect, its first dedicated ultrasound contrast delivery system engineered to support cardiology imaging specifically, has received 510(k) clearance from the FDA and authorisation from Health Canada.
The company says these regulatory milestones represent the first step in its broader global commercialisation strategy for VueJect. VueJect will initially be available in the United States and Canada, with additional regulatory submissions planned in other markets.
VueJect expands Bracco’s growing CEUS ecosystem by providing a dedicated contrast delivery solution designed to improve workflow efficiency through a streamlined administration process; reduce operator variability leading to consistency during contrast administration; and enable continuous administration of ultrasound contrast agents to support more consistent enhancement during cardiac imaging procedures.
“VueJect represents a significant strategic milestone for Bracco as we continue investing in innovations that advance contrast-enhanced ultrasound worldwide,” said Fulvio Renoldi Bracco, Vice Chairman and CEO, Bracco Imaging. “Beginning with regulatory approvals in the United States and Canada, VueJect further advances our integrated ultrasound portfolio and reflects our commitment to expanding access to innovative diagnostic solutions around the world.”
“VueJect is a defining addition to our CEUS ecosystem, adding a dedicated injector to our Ultrasound-Enhancing Agent portfolio that is able to administer Lumason/SonoVue in dilution in Echocardiography procedures,” said Luca Frazzoli, Global Head of Ultrasound, Bracco Imaging. “As we bring this technology to more markets, we expect it to change what sonographers and physicians come to expect from contrast administration, setting a new standard for consistency and confidence in everyday practice.”
“FDA clearance and Health Canada authorisation mark an important milestone for clinicians across North America,” said Robert Mitchell, MBA, Director, Ultrasound Platform, Americas. “VueJect provides cardiac sonographers with a more standardised approach to contrast administration, helping deliver more consistent CEUS examinations, day in and day out.”
Following these regulatory milestones in the United States and Canada, Bracco says it is preparing for commercial launch while advancing plans for future regulatory submissions in additional global markets. VueJect marks the latest step in Bracco’s investment in contrast-enhanced ultrasound.
VueJect has received 510(k) clearance from the U.S. FDA and is licensed by Health Canada under Medical Device License No. 115637. For complete operating instructions, warnings, precautions, and other important safety information, refer to the instructions for use.
