Bracco Imaging Secures FDA Approval and Health Canada Authorization for VueJect®, an Innovative Ultrasound Contrast System

Bracco Imaging has achieved significant regulatory milestones with the 510(k) clearance from the U.S. Food and Drug Administration (FDA) and authorization from Health Canada for VueJect®, the company's proprietary ultrasound contrast delivery system. Designed specifically for cardiology imaging, VueJect® is set to enhance the administration of contrast agents in contrast-enhanced ultrasound (CEUS) procedures.

VueJect® plays a pivotal role in Bracco's strategic plan to create a more efficient and standardized CEUS ecosystem. The device is engineered to optimize workflow by streamlining the process of contrast agent administration, thus reducing variability among operators and ensuring consistent enhancement during cardiac imaging. This advancement is expected to elevate the standards of contrast administration practices among sonographers and healthcare providers.

Fulvio Renoldi Bracco, Vice Chairman and CEO of Bracco Imaging, stated, "VueJect represents a significant strategic milestone for Bracco as we continue investing in innovations that advance contrast-enhanced ultrasound worldwide." With the approvals in the United States and Canada, Bracco intends to expand VueJect's reach by submitting additional regulatory applications globally.

Luca Frazzoli, Global Head of Ultrasound at Bracco Imaging, highlighted, "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.” This development aligns with Bracco's mission to provide innovative diagnostic solutions and improve access for clinicians worldwide.

VueJect's regulatory approvals in North America mark a significant advancement for cardiac sonographers, as noted by Robert Mitchell, 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."

As the company moves forward with VueJect’s commercial launch, it is simultaneously preparing for further regulatory submissions in various international markets, reinforcing its investment in advancing CEUS technology.