Ultrasound Contrast Delivery System Receives FDA Clearance

Aug. 11, 2026 — Bracco Imaging recently announced that VueJect, its dedicated ultrasound contrast delivery system engineered to support cardiology imaging specifically, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and authorization from Health Canada.

These regulatory achievements represent the first step in Bracco's broader global commercialization strategy for VueJect, reinforcing the company's long-term commitment to advancing contrast-enhanced ultrasound (CEUS). VueJect will initially be available in the United States and Canada, with additional regulatory submissions planned in other markets.

VueJect Helps Expands Bracco's CEUS Offerings 

VueJect provides a dedicated contrast delivery solution designed to:

• Improve workflow efficiency through a streamlined contrast administration process

• Reduce operator variability leading to consistency during contrast administration

• 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 authorization mark an important milestone for clinicians across North America," said Robert Mitchell, MBA, Director, Ultrasound Platform, Americas. "VueJect provides cardiac sonographers with a more standardized 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 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.