Bracco Imaging has secured 510(k) clearance from the US FDA and Health Canada authorisation for VueJect, the first dedicated ultrasound contrast delivery system engineered specifically for cardiology imaging.
What VueJect Does
VueJect is designed to continuously administer Bracco's Lumason/SonoVue ultrasound-enhancing agent in dilution during echocardiography procedures, aiming to reduce operator variability and standardise contrast delivery across cardiac exams. It has been licensed by Health Canada under Medical Device License No. 115637, according to Bracco.
Why It Matters
Contrast-enhanced ultrasound is one of the fastest-growing modalities in cardiac imaging, prized for avoiding CT radiation and MRI cost while giving sharper views of the left ventricle. Yet, until now, injectors used for these exams were general-purpose devices adapted from other imaging workflows. A dedicated injector — sized, calibrated and workflow-tuned for cardiac ultrasound — is the missing piece the modality has needed to scale. Bracco Imaging CEO Fulvio Renoldi Bracco called it "a significant strategic milestone" as the company builds out its contrast-enhanced ultrasound ecosystem worldwide.
Rollout
The system will launch initially in the US and Canada, with additional regulatory submissions planned for other markets, according to the company. The clearance sits alongside Bracco's other 2026 imaging bets, including AI-augmented MRI enhancement software developed with Subtle Medical. For context on the broader radiology-AI clearance wave, see previous coverage of DeepHealth's Smart B-See ultrasound AI and Implicity's ILR ECG analyzer.
The Numbers Behind AI Imaging Clearances
The FDA has now cleared more than 1,500 AI-based imaging algorithms, with radiology accounting for over three quarters of them and the agency clearing roughly 30 medical AI devices per month. VueJect is a hardware — not algorithm — clearance, but sits in the same broader wave of imaging workflow modernisation reshaping how contrast studies are administered.
Reporting based on coverage from Medical Device Network, DAIC and BioSpace.