Bracco Launches VUEWAY® Injection in Mexico Following Regulatory Approval

Bracco Imaging has announced the commercial release of VUEWAY® injection (gadopiclenol) in Mexico, following approval by the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) for its use in contrast-enhanced MRI. This approval is pertinent for both adults and children aged two years and older, reflecting Bracco's ongoing commitment to enabling lower-dose MRI procedures globally.

VUEWAY® injection is designed to enhance contrast during MRI examinations while minimizing gadolinium exposure. This aligns with current radiological practices that recommend using the lowest effective dose of gadolinium-based contrast agents (GBCAs) for optimal patient safety. As part of Bracco’s strategic expansion into Latin America, the introduction of this innovative agent in Mexico is seen as a significant step in improving diagnostic imaging standards.

"The launch of VUEWAY® injection in Mexico is pivotal in our strategy for Latin America," stated Tommaso Montemurno, General Manager for Latin America at Bracco Imaging. "This product supports advanced MRI imaging, offering healthcare professionals broader diagnostic options and contributing to enhanced imaging quality."

Further emphasizing its impact, Hector Sanchez, Commercial Director for Mexico at Bracco Imaging, remarked on the innovation introduced with VUEWAY® injection in the diagnostic imaging field. He praised the contrast agent's unique profile, which aids in high-quality imaging while maintaining a high standard for patient safety.

This recent approval by COFEPRIS follows similar regulatory successes in the United States, Canada, and the European Union. Notably, in these regions, the use of VUEWAY® has been approved for neonates and infants, broadening its application scope. Globally, VUEWAY® injection is authorized in 38 countries, with over four million doses administered.

Gadopiclenol, a macrocyclic gadolinium-based contrast agent initially developed by Guerbet and furthered by Bracco with intellectual property contributions, exhibits high relaxivity and has been extensively evaluated for its efficacy and safety across a range of bodily systems. The FDA in the U.S. and the EMA in Europe have both approved its use from birth, underscoring its safety and versatility in pediatric populations.