Bracco Imaging is launching Vueway (gadopiclenol) injections in Mexico following approval from the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS), the country's regulatory authority, in September 2025.
The gadolinium-based contrast agent is approved for contrast-enhanced MRI in adults and children 2 years and older, according to the company. Bracco said the agent supports reduced gadolinium exposure while maintaining effective contrast enhancement, aligning with radiology society guidance favoring the lowest effective dose for gadolinium-based contrast agents.
The COFEPRIS approval follows earlier regulatory clearances in the European Union, the U.S., and Canada, where the approved indication extends to neonates and infants, Bracco noted. Vueway is now approved in 38 countries, with more than 4 million patient doses administered, the company said.
