Approval supports responsible imaging through effective contrast enhancement at a lower gadolinium dose

MEXICO CITY, July 21, 2026 /PRNewswire/ — Bracco Imaging, a global leader in diagnostic imaging, today announced the commercial availability of VUEWAY^® injection (gadopiclenol), which received approval in September 2025 from the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS), Mexico’s regulatory authority, for use in contrast-enhanced magnetic resonance imaging (CE-MRI) in adults and children aged 2 years and older.

VUEWAY^® has demonstrated effective contrast enhancement resulting in reduced gadolinium exposure for patients.^1,2,3 This approach aligns with clinical guidance from radiology societies, which emphasizes the use of the lowest effective GBCA dose when contrast-enhanced imaging is required.³  

“The launch of VUEWAY^® injection in Mexico represents an important milestone in the consolidation of our strategy in Latin America,” said Tommaso Montemurno, General Manager for Latin America at Bracco Imaging. “This innovative contrast agent expands access to advanced MRI imaging in Mexico, supporting high-quality diagnostic performance and addressing the evolving needs of clinical practice. With VUEWAY^® injection, we continue to strengthen our MRI portfolio, broaden the options available to healthcare professionals, and contribute to the advancement of diagnostic imaging across the region.”

“The introduction of VUEWAY^® injection in Mexico marks a key milestone in strengthening innovation in diagnostic imaging. As a next-generation contrast agent, VUEWAY^® injection offers a differentiated profile that enables healthcare providers to achieve high-quality imaging with confidence, while maintaining a strong commitment to patient safety,” said Hector Sanchez, Commercial Director for Mexico at Bracco Imaging. 

The COFEPRIS approval follows other regulatory milestones in the European Union (EU), United States (US) and Canada. VUEWAY^® injection is now approved in 38 countries worldwide, where more than 4 million patient doses have been administered. In the EU and the US, the approved indication has been extended to include neonates and infants.^4,5,6

About Gadopiclenol
Gadopiclenol, initially invented by Guerbet with subsequent contribution of Bracco IP, is a new macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity. The efficacy and safety of Gadopiclenol have been evaluated in MRI of the Central Nervous System, head and neck, thorax, abdomen, pelvis, and musculoskeletal system (refer to the approved USPI and Core SPC for full information).
The product has been also approved for use on paediatric population from birth by FDA in US and EMA in Europe.
Details on Phase III clinical trials are available on www.ClinicalTrials.gov:

• Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI) Full Text View – ClinicalTrials.gov
• Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI) Full Text View –gov

THE BRACCO IMAGING AND GUERBET COLLABORATION 
Bracco Imaging and Guerbet in December 2021 entered a worldwide collaboration on Gadopiclenol manufacturing and research and development activities. Gadopiclenol is being commercialized independently under separate brands. Both Guerbet and Bracco Imaging each own valuable intellectual property on Gadopiclenol. Both companies manufacture the product.
The strategic collaboration is expected to accelerate access to Gadopiclenol and deliver innovation, as well as better care to patients and caregivers alike.

About Bracco 
Bracco Group, founded in 1927, is a global leader in diagnostic imaging, committed to advancing healthcare and improving people’s lives by shaping the future of prevention and precision medicine.

The company operates in the healthcare sector across more than 100 countries with a workforce of over 4,000 employees and consolidated annual revenues of approximately €2 billion, 88% generated by international markets.

With a strong commitment to innovation – investing around 9% of its reference turnover in Research & Development – Bracco develops and provides a broad portfolio of pharmaceutical products for diagnostic imaging, including contrast agents for X-ray, Computed Tomography (CT), and Magnetic Resonance Imaging (MRI), as well as microbubbles for Contrast Enhanced Ultrasound (CEUS), and Molecular Imaging through radioactive tracers and novel PET imaging agents, alongside AI-based solutions. It is also a global market leader in advanced contrast management technologies for cardiovascular angiography and radiology imaging.

Discover more at www.bracco.com.

VUEWAY is a registered trademark of Bracco Imaging S.p.A. 

All other trademarks and registered trademarks are the property of their respective owners. 

^©2026 Bracco Diagnostics Inc. All Rights Reserved.

Media Contact: 
Monica Rentschler
Bracco Diagnostics Inc., Assoc. Director, Marketing Communications, Americas
T +1 609.514.2382
BDIMediaContact@diag.bracco.com

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¹Robic 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.
²Hao 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.
³Kanal 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.
⁴Data on file 4 million VW Calculator (19-MAR-2026).
⁵U.S. Food and Drug Administration: 2022 Novel Drug Approvals (gadopiclenol).
⁶European Medicines Agency European Commission decision on VUEWAY.

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SOURCE Bracco Group