Bracco Imaging has received U.S. Food and Drug Administration (FDA) 510(k) clearance and authorization from Health Canada for its VueJect cardiac ultrasound contrast delivery system.
VueJect is intended to support continuous administration of ultrasound contrast agents during cardiac imaging procedures, reducing operator variability and streamlining contrast administration workflows, according to the vendor. The system is designed for use with Bracco's Lumason/SonoVue ultrasound-enhancing agent in echocardiography procedures, Bracco said.
The firm said it plans commercial launch in the U.S. and Canada following the regulatory clearances, with additional regulatory submissions planned in other markets.
