New Ultrasound Contrast Delivery System Garners FDA 510(k) Clearance

The Food and Drug Administration (FDA) has granted 510(k) clearance for the VueJect ultrasound contrast delivery system, which may facilitate enhanced consistency and efficiency in cardiac ultrasound imaging.

Bracco Imaging, the manufacturer of VueJect, said the contrast delivery system, which also received Health Canada authorization, provides a streamlined approach to contrast-enhanced ultrasound that reduces operator variability and fosters greater consistency with enhancement during cardiac imaging.

For echocardiography exams, VueJect’s dedicated injector enables diluted administration of the ultrasound contrast agent marketed as Lumason in the United States and SonoVue in Canada, according to Bracco Imaging.

"VueJect provides cardiac sonographers with a more standardized approach to contrast administration, helping deliver more consistent CEUS examinations, day in and day out,” noted Robert Mitchell, MBA, the director of ultrasound platform for Bracco Imaging Americas.