FDA Approves VUEWAY, Halving MRI Contrast Dose for Infants

PRINCETON, NJ – February 23, 2026 – The U.S. Food and Drug Administration (FDA) has approved Bracco's VUEWAY® (gadopiclenol) injection for use in the youngest and most vulnerable patients: neonates and infants. The decision marks a significant advancement in pediatric medicine, providing a magnetic resonance imaging (MRI) contrast agent that delivers diagnostic-quality images at half the standard dose of gadolinium, addressing long-standing concerns about chemical exposure in developing bodies.

VUEWAY, a macrocyclic gadolinium-based contrast agent (GBCA), can now be used in patients from birth through adulthood. Its key differentiator is a required dose of 0.05 mmol/kg, compared to the 0.1 mmol/kg dose typical for other approved macrocyclic agents in the United States. This reduction directly supports clinical guidelines from leading radiology societies that advocate for using the lowest effective GBCA dose possible.

A New Standard for Pediatric Safety

For decades, clinicians have navigated a difficult balance in pediatric imaging: the need for clear, decisive diagnostic images versus the imperative to protect children from potential long-term risks. While MRIs are favored over CT scans to avoid ionizing radiation, the use of GBCAs has been a subject of ongoing discussion. Studies have confirmed that small amounts of gadolinium can be retained in the body, including the brain and bones, for months or years. While no adverse health effects have been definitively linked to this retention in patients with normal kidney function, the uncertainty is magnified when treating newborns and infants whose organs and tissues are still in critical stages of development.

This approval directly confronts that challenge. "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, MD, MA, FACR, Director of Fetal and Pediatric MR Imaging 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 principle of minimizing exposure is especially relevant for children who may require multiple contrast-enhanced MRIs throughout their lives for chronic conditions, potentially leading to higher cumulative doses over time. The availability of an agent that cuts the dose for each scan in half is a pivotal step toward mitigating this concern.

The Science of High Efficacy, Low Dose

The ability of VUEWAY to perform effectively at a reduced dose is rooted in its molecular structure. It is a highly stable macrocyclic GBCA, a class of agents considered safer due to their cage-like structure that tightly binds the gadolinium ion, reducing the risk of it being released into the body. Furthermore, gadopiclenol has the highest relaxivity—a measure of a contrast agent's efficiency in enhancing the MRI signal—among all currently approved GBCAs. This high efficiency is what enables it to produce clear, comparable images to full-dose agents like gadobutrol, a fact demonstrated in large, multicenter clinical trials.

This balance of efficacy and safety gives clinicians a powerful new tool. "Imaging neonates and infants demands both precision and restraint," stated Jeffrey H. Miller, MD, a Pediatric Neuroradiologist and Chief of Radiology at Phoenix Children's Hospital. "The availability of a contrast agent that delivers strong visualization at a lower gadolinium dose gives clinicians another tool to balance diagnostic confidence with thoughtful exposure management. For practices caring for children who may require multiple MRIs over time, this represents a practical and clinically meaningful advancement."

The FDA's approval was based on findings from the GDX-44-015 study, which specifically evaluated the safety and efficacy of VUEWAY in pediatric patients, solidifying its profile for this sensitive population.

Navigating a Shifting Regulatory and Market Landscape

The approval arrives at a time of heightened global scrutiny over GBCA safety. Regulatory bodies worldwide have been re-evaluating the risk-benefit profile of these agents. The European Medicines Agency (EMA) has taken a particularly cautious stance, restricting the use of less stable linear GBCAs and emphasizing the use of macrocyclic agents at the lowest effective dose. The FDA has also mandated class-wide warnings about gadolinium retention.

Bracco's VUEWAY, and the similar agent Elucirem from partner Guerbet, are well-positioned within this safety-conscious environment. The development of a half-dose agent signals a proactive industry response to the demands of regulators and clinicians for safer alternatives. The initial FDA approval for VUEWAY in adults in 2022 was granted Priority Review, a designation reserved for drugs that may offer significant improvements in safety or effectiveness.

This expanded indication for neonates is expected to significantly bolster Bracco's market position. The company reports that over 3.5 million doses of VUEWAY have already been administered across approximately 900 sites in the U.S. since its initial launch, indicating strong clinical adoption and a clear preference for lower-dose options. By securing approval for the entire pediatric age range, Bracco is now able to serve a critical market segment where safety is the paramount consideration for purchasing decisions by hospitals and imaging centers.

Beyond patient safety, the lower dose aligns with a growing movement toward responsible contrast stewardship and sustainability in healthcare. "Limiting gadolinium amounts in production and in medical waste supports responsible contrast stewardship, which is an increasing focus for radiology sustainability efforts," Dr. Chapman added. This dual benefit of enhanced patient safety and reduced environmental impact further strengthens the agent's appeal in a modern healthcare setting. This focus on minimizing exposure while maximizing diagnostic value is poised to define the next generation of medical imaging standards for all patients, from the smallest newborns to the elderly.