The FDA has approved an expanded indication for VUEWAY (gadopiclenol) injection, allowing its use in neonates and infants. The decision extends the contrast agent’s label from birth through adulthood.

VUEWAY is a macrocyclic gadolinium-based contrast agent (GBCA) administered at 0.05 mmol/kg, half the gadolinium dose of other macrocyclic GBCAs approved in the United States, which are typically dosed at 0.1 mmol/kg. The lower dose is intended to reduce cumulative gadolinium exposure while maintaining diagnostic performance during contrast-enhanced MR exams.

Clinical guidance from radiology societies recommends using the lowest effective GBCA dose, particularly in pediatric populations. Neonates and infants are considered a sensitive group because of ongoing brain and organ development and the potential for repeat imaging.
“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,” said Teresa Chapman, M.D., MA, FACR, director of fetal and pediatric MR imaging in the department of radiology at the University of Wisconsin School of Medicine & Public Health. “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. An FDA-approved contrast agent that provides our required diagnostic quality with half the gadolinium dose represents meaningful progress for pediatric MRI.”

The approval was based on data from the GDX-44-015 study evaluating safety and efficacy in pediatric patients. According to Bracco, the Princeton, New Jersey-based manufacturer, more than 3.5 million doses have been administered in the U.S. since the agent’s initial FDA approval in September 2022. Gadopiclenol received European approval for adults and children 2 years and older in 2023, with an expanded EU indication for neonates and infants granted in January 2026.

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