Bracco Imaging has secured 510(k) clearance from the US Food and Drug Administration (FDA) and authorisation from Health Canada for VueJect®, a dedicated ultrasound contrast delivery system designed for cardiac imaging.
The regulatory milestones support Bracco’s broader commercialisation strategy for VueJect, which will initially be introduced in the US and Canada.
The company plans to pursue regulatory submissions in additional international markets.
VueJect is designed to simplify contrast administration during contrast-enhanced ultrasound (CEUS) and echocardiography procedures.
The system aims to improve workflow efficiency through a streamlined delivery process and reduce operator variability, supporting greater consistency during contrast administration.
It also enables continuous administration of ultrasound contrast agents to help maintain consistent enhancement during cardiac imaging.
The technology expands Bracco’s CEUS portfolio by providing a dedicated delivery solution for administering Lumason/SonoVue in dilution during echocardiography procedures.
The system is intended to support sonographers and physicians with a more standardised approach to contrast administration.
Following the US and Canadian regulatory clearances, Bracco is preparing for the commercial launch of VueJect while advancing plans for regulatory submissions in other markets.
VueJect is licensed by Health Canada under Medical Device Licence No. 115637. Complete operating instructions, warnings, precautions and safety information are provided in the product’s instructions for use.
