FDA Expands Approval of Low-Dose MRI Contrast Agent to Include Neonates and Infants

Feb. 23, 2026 — Bracco, a global leader in diagnostic imaging, recently announced that the U.S. Food and Drug Administration (FDA) has approved the extension of the current Vueway (gadopiclenol) solution for injection, intravenous use, for use in neonates and infants.

Vueway injection is a macrocyclic gadolinium-based contrast agent (GBCA) that provides effective contrast enhancement at half the gadolinium dose (0.05 mmol/kg) compared with other macrocyclic GBCAs approved in the United States (0.1 mmol/kg), helping reduce cumulative gadolinium exposure without compromising image quality.^1,2,3 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.⁴ Clinical guidance from radiology societies emphasizes the use of the lowest effective GBCA dose when contrast-enhanced imaging is required.⁴

"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, Department of Radiology, 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.  Additionally, limiting gadolinium amounts in production and in medical waste supports responsible contrast stewardship, which is an increasing focus for radiology sustainability efforts."

Vueway injection is a highly stable macrocyclic GBCA with the highest longitudinal relaxivity (r1) values among currently approved GBCAs. 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.^5,6,7

"Imaging neonates and infants demands both precision and restraint," said Jeffrey H. Miller, MD, 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."

More than 3.5 million doses of Vueway injection have been administered across approximately 900 customer sites in the U.S., reflecting growing clinical adoption and patient preference for lower-dose contrast agents.^8,9

"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 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.^10,11 In January 2026, gadopiclenol received EU approval expanding its approved indications to include neonates and infants.¹¹

Vueway is available in single-dose vials, single-dose prefilled syringes, pharmacy bulk packages, and imaging bulk packages.

Go to www.bracco.com for more information.

1. Vueway (gadopiclenol) solution for injection, intravenous use. Full Prescribing Information and Patient Medication Guide. Princeton, NJ: Bracco Diagnostics Inc.; December 2025.
2. Loevner LA, Kolumban B, Hutóczki G, et al. Efficacy and safety of gadopiclenol for contrast-enhanced MRI of the central nervous system: the PICTURE randomized clinical trial. Invest Radiol. 2023 May;58(5):307-313.
3. Kuhl C, Csőszi T, Piskorski W, Miszalski T, Lee JM, Otto PM. Efficacy and safety of half-dose gadopiclenol versus full-dose gadobutrol for contrast-enhanced body MRI. Radiology. 2023 Jul; 308(1): e222612
4. American College of Radiology. ACR Manual on Contrast Media. 2025. Available at: www.acr.org/Clinical-Resources/Clinical-Tools-and-Reference/Contrast-Manua. Accessed January 29, 2026.
5. Robic C, Port M, Rousseaux O, Louguet S, Fretellier N, Catoen S, Factor C, Le Greneur S, Medina C, Bourrinet P, Raynal I, Idée JM, Corot C. Physicochemical and Pharmacokinetic Profiles of Gadopiclenol: A New Macrocyclic Gadolinium Chelate With High T1 Relaxivity. Invest Radiol 2019; 54(8):475-484.
6. Hao J, Pitrou C, Bourrinet P. A Comprehensive Overview of the Efficacy and Safety of Gadopiclenol: A New Contrast Agent for MRI of the CNS and Body. Invest Radiol 2024; 59(2):124-130.
7. Kanal E, Maki JH, Schramm P, Marti-Bonmati L. Evolving Characteristics of Gadolinium-Based Contrast Agents for MR Imaging: A Systematic Review of the Importance of Relaxivity. J Magn Reson Imaging 2025; 61(1):52-69.
8. Data on file. Three Million Doses. Bracco Diagnostics Inc.; September 2025.
9. Data on file. No. of Accounts. Bracco Diagnostics Inc.; September 2025.
10. U.S. Food and Drug Administration: 2022 Novel Drug Approvals (gadopiclenol). Available at: www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2022. Accessed on January 27, 2026.
11. European Medicines Agency European Commission decision on VUEWAY. Available at: www.ema.europa.eu/en/medicines/human/EPAR/vueway#authorisation-details. Accessed on January 28, 2026.