Bracco Imaging has obtained 510(k) clearance from the US Food and Drug Administration (FDA) and Health Canada authorisation for VueJect, a contrast delivery system designed for use in cardiology imaging.

VueJect is designed to support imaging procedures by delivering ultrasound contrast agents.

The device will be sold initially in the US and Canada, with further submissions planned in additional markets.

The system provides a dedicated solution for the administration of ultrasound contrast agents, aiming to make contrast delivery consistent during imaging procedures.

VueJect is intended to improve workflow and reduce operator variability.

Bracco Imaging vice-chairman and CEO Fulvio Renoldi Bracco said: “VueJect represents a significant strategic milestone for Bracco as we continue investing in innovations that advance contrast-enhanced ultrasound worldwide.

“Beginning with regulatory approvals in the US and Canada, VueJect further advances our integrated ultrasound portfolio and reflects our commitment to expanding access to innovative diagnostic solutions around the world.”

Bracco Imaging ultrasound global head Luca Frazzoli said: “VueJect is a defining addition to our CEUS [contrast-enhanced ultrasound] ecosystem, adding a dedicated injector to our ultrasound-enhancing agent portfolio that is able to administer Lumason/SonoVue in dilution in Echocardiography procedures.

“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.”

VueJect has been licensed by Health Canada under Medical Device License No. 115637.

In June 2025, Bracco Imaging and Subtle Medical obtained an EU CE mark for AiMIFY, a jointly developed software designed to enhance the imaging of contrast MRI brain scans using AI.