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European Commission Approves Vueway® for Pediatric Use

In a significant development for pediatric healthcare, the European Commission (EC) has extended the Marketing Authorisation for Vueway® (gadopiclenol) to include its use in children under the age of 2. This decision, announced by Bracco Imaging S.p.A. on January 27, 2026, underscores the continued advancement in medical technology tailored for younger patients.

Background on Vueway® (gadopiclenol)

Vueway® is a macrocyclic gadolinium-based contrast agent (GBCA) designed to enhance Magnetic Resonance Imaging (MRI) examinations. It allows medical professionals to visualize certain pathologies that may not be easily detected otherwise. As of January 2026, Vueway® has been approved in 36 countries, with its primary function being to improve imaging diagnostic capabilities.

Initially approved in December 2023 for usage in adults and children aged two years and older, Vueway® is instrumental in conducting contrast-enhanced MRIs. The scans focus on specific areas such as the brain, spine, liver, kidney, and other critical regions, particularly where disruption of the blood-brain barrier (BBB) or abnormal vascularity may be present.

Approval Process and Safety Assessments

The EC's recent approval came after a favorable opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The assessment emphasized the positive balance between benefits and risks associated with administering Vueway® to younger patients. Specifically, the approval involved extensive studies demonstrating the effectiveness and safety of Vueway® in infants and toddlers.

On December 11, 2025, the CHMP recognized the established safety profile and diagnostic efficacy of the GBCA, reinforcing the substantial need for effective imaging solutions in this vulnerable population.

Advantages of Vueway®

Vueway® boasts the highest relaxivity among currently approved GBCAs, which means that it can provide effective imaging at lower doses than previously used agents, such as gadobutrol. This is particularly important for reducing patient exposure to gadolinium, a rare earth metal with unique properties beneficial for MRI but also linked to potential long-term effects if retained in the body. Alberto Spinazzi, Chief Medical Regulatory Officer of Bracco Group, highlighted that minimizing gadolinium exposure without compromising diagnostic quality is critical, particularly for neonates and infants whose health conditions are not fully understood.

Clinical Implications

The extension of Vueway® for infants aims to fulfill a crucial need in pediatric imaging. The approval represents a leap forward in the ability to diagnose and identify health conditions at an early age, allowing for timely interventions that can significantly improve health outcomes.

Gadolinium-based contrast agents have become essential in modern medicine, enhancing the diagnostic power of MRIs. Through initiatives like Vueway®, Bracco Imaging is dedicated to leading innovation in this field, ensuring that pediatric patients receive the highest standard of care.

Conclusion

As Bracco Imaging continues to expand its presence in key markets, the EU's endorsement of Vueway® for pediatric use highlights its commitment to enhancing health diagnostics. The collaboration between various regulatory bodies ensures that advanced imaging technology is both accessible and beneficial for even the youngest patients, promoting a better understanding of pediatric health challenges and improving the efficacy of medical interventions.

For more detailed information about Bracco Imaging and Vueway®, please visit Bracco Imaging.