The U.S. Food and Drug Administration (FDA) has expanded the approval of VUEWAY® (gadopiclenol) solution for injection, allowing its use in neonates and infants undergoing magnetic resonance imaging (MRI). This approval offers clinicians a valuable option for contrast-enhanced MRI in the youngest patients, delivering diagnostic confidence although reducing gadolinium exposure, a key concern in developing brains and bodies. The decision, announced on February 23, 2026, reflects a positive benefit-risk profile for the contrast agent across all age groups.
Gadopiclenol distinguishes itself from other macrocyclic gadolinium-based contrast agents (GBCAs) by providing effective contrast enhancement at half the standard gadolinium dose – 0.05 mmol/kg compared to 0.1 mmol/kg, according to the FDA approval. This lower dose is particularly crucial for neonates and infants, whose brains and body tissues are still developing, minimizing cumulative gadolinium exposure.
Lower Gadolinium Dose, High-Quality Imaging
The approval extends the use of VUEWAY® (gadopiclenol) to detect and visualize lesions with abnormal vascularity in both the central nervous system (brain, spine, and associated tissues) and throughout the body, including the head, neck, thorax, abdomen, pelvis, and musculoskeletal system. Guerbet, the manufacturer of Elucirem™ (gadopiclenol), highlighted that their innovation is the first gadolinium-based contrast agent approved at a half dose of gadolinium, while also boasting the highest relaxivity compared to other available GBCAs. This means it provides a strong signal for clearer images with less of the contrast agent.
“Reducing gadolinium exposure while maintaining diagnostic performance is important for all patients undergoing contrast-enhanced MRI, and is particularly critical in neonates and infants, whose brains and body tissues are still developing,” the FDA stated in its approval. Clinical guidance from radiology societies already emphasizes using the lowest effective GBCA dose when contrast-enhanced imaging is necessary.
Expert Perspective on Pediatric Imaging
Dr. Teresa Chapman, Director of Fetal and Pediatric MR Imaging at the University of Wisconsin School of Medicine & Public Health, emphasized the importance of considering long-term implications when caring for vulnerable patients. “In the delivery of medical care, and particularly for our care of neonates and young children, we must consider potential long-term implications of our decisions today,” Dr. Chapman said. “For diagnostic magnetic resonance imaging exams that require intravenous gadolinium contrast, we have a responsibility to achieve high-quality imaging while reducing cumulative exposure to gadolinium.”
The approval builds on previous milestones for gadopiclenol. The agent was initially approved by the FDA in September 2022 and by the European Medicines Agency (EMA) in December 2023. It is manufactured in both France and the United States.
What’s Next for Gadopiclenol and Pediatric MRI
The expanded approval of gadopiclenol represents a significant step forward in pediatric diagnostic imaging, offering a safer and more effective option for contrast-enhanced MRI in infants and neonates. Further research will likely focus on long-term outcomes and optimal protocols for gadopiclenol use in this vulnerable population. Clinicians are encouraged to stay updated on the latest guidelines and best practices for GBCA administration in pediatric patients.
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Disclaimer: This article provides informational content and should not be considered medical advice. Always consult with a qualified healthcare professional for diagnosis and treatment of any medical condition.
