The FDA has approved an expanded indication for Vueway (gadopiclenol) solution for injection, enabling its use in neonates and infants undergoing contrast-enhanced magnetic resonance imaging (MRI).
The approval was granted to Italy-based diagnostic imaging specialist Bracco.
The decision marks a significant advancement in pediatric imaging, extending the agent’s use across the full age spectrum, from birth through adulthood.
Originally approved in 2022 for adults and children aged two years and older, gadopiclenol is a macrocyclic gadolinium-based contrast agent (GBCA) designed to enhance visualization of lesions with abnormal vascularity in the central nervous system and across the body.
The latest FDA action broadens its clinical utility to the youngest and most vulnerable patient populations, addressing a longstanding gap in pediatric imaging.
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A key differentiator of gadopiclenol is its ability to deliver high-quality contrast enhancement at half the gadolinium dose (0.05 mmol/kg) compared with other macrocyclic GBCAs, which typically require 0.1 mmol/kg. This reduced dose is particularly important in neonates and infants, whose developing brains and tissues may be more susceptible to the potential long-term effects of gadolinium exposure.
Radiology guidelines emphasize using the lowest effective dose of contrast agents, especially in pediatric populations. By maintaining diagnostic performance while lowering cumulative gadolinium exposure, gadopiclenol aligns with these safety-driven recommendations.
The FDA’s decision was supported by clinical data demonstrating the safety and efficacy of gadopiclenol in pediatric patients, including those under two years of age. Studies have shown that imaging with gadopiclenol at half-dose provides comparable image quality to conventional full-dose agents such as gadobutrol.
Importantly, no new safety signals were identified in neonates and infants. The agent’s high relaxivity, greater than many existing GBCAs, enables this dose reduction without compromising diagnostic accuracy.
In the press release announcing the approval, Bracco shared that more than 3.5 million doses of Vueway injection have been administered across approximately 900 customer sites in the US, “reflecting growing clinical adoption and patient preference for lower-dose contrast agents.”
“When imaging is needed early in life, families want reassurance that every decision has been made with long-term safety in mind,” said Gary Ray, Associate Director, MR Contrast, Bracco Americas. “This FDA approval provides clinicians with an approved option for contrast-enhanced MRI in neonates and infants that delivers diagnostic confidence at a lower gadolinium dose. By extending Vueway injection to patients from birth, we are helping support essential imaging while being intentional about exposure in populations where long-term considerations matter most.”
The expanded pediatric indication is expected to further strengthen its role in clinical practice, particularly in hospitals and imaging centers prioritizing safety in vulnerable populations.
Vueway is in a competitive market of GBCAs used in MRI. Its main competitors are macrocyclic agents such as gadobutrol from Bayer, gadoterate meglumine from Guerbet and gadoteridol from Bracco, which are widely used due to their strong safety profiles.
Gadopiclenol differentiates itself by delivering comparable image quality at about half the standard gadolinium dose, an advantage that is particularly important in neonates and infants.
Older linear agents like gadodiamide from GE HealthCare are used less frequently due to safety concerns.
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