The injection provides contrast enhancement at half the standard gadolinium dose, reducing exposure in developing patients.
The US Food and Drug Administration (FDA) has approved Vueway (gadopiclenol) solution for injection for use in neonates and infants, expanding low-dose MRI contrast options for the youngest patients.
Vueway injection is a macrocyclic gadolinium-based contrast agent that provides effective contrast enhancement at half the gadolinium dose (0.05 mmol/kg) compared with other macrocyclic GBCAs approved in the US (0.1 mmol/kg). The approval helps reduce cumulative gadolinium exposure without compromising image quality, which is particularly important for neonates and infants whose brains and body tissues are still developing.
“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,” says Teresa Chapman, MD, MA, FACR, director of fetal and pediatric MR imaging in the department of radiology at University of Wisconsin School of Medicine & Public Health, in a release. “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.”
Clinical Performance Data
Vueway injection is a highly stable macrocyclic GBCA with the highest longitudinal relaxivity values among currently approved GBCAs, according to Bracco Imaging, which markets Vueway in the United States through Bracco Diagnostics Inc. Large, multicenter clinical studies have demonstrated that Vueway injection provides comparable diagnostic efficacy at half the gadolinium dose of gadobutrol, a GBCA widely used in clinical practice.
More than 3.5 million doses of Vueway injection have been administered across approximately 900 customer sites in the US, reflecting growing clinical adoption of lower-dose contrast agents.
“Imaging neonates and infants demands both precision and restraint,” says Jeffrey H Miller, MD, pediatric neuroradiologist and chief of radiology at Phoenix Children’s Hospital, in a release. “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.”
Approval Details
The FDA approval was based on data from study GDX-44-015, which evaluated the safety and efficacy of Vueway injection in pediatric patients. Gadopiclenol was first approved by the FDA in September 2022 and obtained EU approval in December 2023 for use in adult patients and in pediatric patients aged 2 years and older. In January 2026, gadopiclenol received EU approval expanding its approved indications to include neonates and infants.
Vueway injection is now indicated in adults and children, including term neonates, for use with MRI to detect and visualize lesions with abnormal vascularity. The agent is available in single-dose vials, single-dose prefilled syringes, pharmacy bulk packages, and imaging bulk packages.
Clinical guidance from radiology societies emphasizes the use of the lowest effective GBCA dose when contrast-enhanced imaging is required. The approval addresses this recommendation while maintaining diagnostic performance standards for pediatric imaging.
“When imaging is needed early in life, families want reassurance that every decision has been made with long-term safety in mind,” says Gary Ray, associate director of MR contrast at Bracco Americas, in a release. “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.”
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