Bracco’s Ultrasound Contrast Delivery System Nabs a Pair of Regulatory Approvals

Bracco Imaging’s VueJect—its first dedicated ultrasound contrast delivery system that specifically supports cardiology imaging—has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and authorization from Health Canada.

The two authorizations represent the first step in Bracco’s broader global commercialization strategy for VueJect, reinforcing its 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.

“FDA clearance and Health Canada authorization mark an important milestone for clinicians across North America,” said Robert Mitchell, director of 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.”

VueJect expands Bracco’s growing CEUS ecosystem by providing 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,” Bracco Imaging Vice Chairman/CEO Fulvio Renoldi Bracco stated. “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.”

Following these authorizations, Bracco is preparing to commercially launch VueJect 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.

“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,” Bracco Imaging Global Head of Ultrasound Luca Frazzoli commented. “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.”

Founded in 1927, Bracco Group develops diagnostic imaging solutions. The company operates in more than 100 countries with a workforce of over 4,000 employees and consolidated annual revenues of approximately €2 billion, with 88% generated by international markets. With a strong commitment to innovation—investing about 9% of its reference turnover in R&D—Bracco develops and provides pharmaceutical products for diagnostic imaging, including contrast agents for X-ray, computed tomography (CT), and magnetic resonance imaging (MRI), as well as microbubbles for CEUS, and molecular imaging through radioactive tracers and PET imaging agents, alongside artificial intelligence (AI)-based solutions. It also provides advanced contrast management technologies for cardiovascular angiography and radiology imaging.