MILAN, Italy, August 11, 2026
Bracco Imaging has announced that its VueJect® ultrasound contrast delivery system has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and authorization from Health Canada, marking a significant regulatory milestone for the company’s contrast-enhanced ultrasound (CEUS) portfolio. Designed specifically to support cardiology imaging, VueJect is Bracco’s first dedicated ultrasound contrast delivery system for cardiac applications. The regulatory clearances represent the first phase of the company’s broader global commercialization strategy, with initial availability planned for the United States and Canada and additional regulatory submissions expected in other markets.
VueJect Designed to Improve Cardiac Imaging Workflow
VueJect® is designed to provide a dedicated solution for the administration of ultrasound contrast agents during cardiac imaging procedures. Bracco said the system is intended to support a more streamlined contrast administration workflow while helping reduce variability between operators. The system can also enable continuous administration of ultrasound contrast agents, which may support more consistent enhancement during echocardiography and other cardiac imaging procedures. By integrating contrast delivery into Bracco’s broader contrast-enhanced ultrasound ecosystem, VueJect is intended to help clinicians achieve a more standardized approach to contrast administration in routine cardiology imaging.
The technology adds a dedicated injector to Bracco’s existing ultrasound-enhancing agent portfolio. According to the company, VueJect is capable of administering Lumason/SonoVue in dilution for echocardiography procedures, creating an integrated approach that combines contrast agents with a dedicated delivery platform. Bracco said the system is expected to support cardiac sonographers and physicians by improving consistency and efficiency during contrast-enhanced ultrasound examinations.
FDA and Health Canada Authorizations Support Launch
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The FDA 510(k) clearance and Health Canada authorization provide important regulatory foundations for the commercial introduction of VueJect in North America. Bracco is preparing for commercial launch in the United States and Canada while planning additional regulatory submissions in other global markets. Health Canada has licensed VueJect under Medical Device License No. 115637. The regulatory progress demonstrates Bracco’s strategy of expanding its CEUS capabilities through dedicated technologies designed for specific clinical workflows. Contrast-enhanced ultrasound uses ultrasound contrast agents to improve visualization during imaging and can provide additional information during cardiovascular examinations. Bracco’s investment in VueJect reflects its broader focus on diagnostic imaging technologies and solutions designed to support more efficient and standardized clinical procedures. The company views the new delivery system as an important addition to its ultrasound portfolio and as part of its long-term strategy to advance access to CEUS technologies worldwide.
Bracco Expands Global CEUS Technology Portfolio
The VueJect milestone adds to Bracco’s broader diagnostic imaging portfolio, which includes contrast agents for X-ray, computed tomography, magnetic resonance imaging, and contrast-enhanced ultrasound, as well as molecular imaging technologies and AI-based solutions. The company operates across more than 100 countries and continues to invest in research and development focused on diagnostic imaging and precision medicine. The launch of a dedicated cardiac contrast delivery platform expands Bracco’s capabilities within CEUS and strengthens its position in the development of integrated imaging solutions.
VueJect’s U.S. FDA clearance and Health Canada authorization represent an important step in Bracco’s effort to expand standardized contrast administration for cardiology imaging. As the company prepares for commercialization in North America and pursues regulatory submissions in additional markets, the technology could contribute to more consistent contrast-enhanced ultrasound workflows. The combination of a dedicated delivery system with Bracco’s ultrasound contrast agent portfolio highlights the company’s continued focus on diagnostic imaging innovation and cardiovascular imaging technology.
Source: Bracco Imaging press release
