Bracco Diagnostics has secured a major FDA approval that expands how radiology departments can deliver MRI contrast. The agency has cleared the VUEWAY® (gadopiclenol) Imaging Bulk Package (IBP) for use with the Max 3™ syringeless MRI injector, giving hospitals a more efficient, flexible, and sustainable way to manage MRI contrast.
This update strengthens Bracco’s position as a leader in high-performance imaging and reinforces its push toward greener, smarter contrast delivery systems.
The Max 3™ system is the first syringeless MRI injector in the U.S. It now supports single-dose vials, multi-dose vials, and the newly approved VUEWAY® IBP in 30 mL and 50 mL formats.
Why this matters:
Hospitals can now tailor contrast delivery to their staffing, throughput, and sustainability needs.
The VUEWAY® IBP allows technologists to draw multiple single doses from one container when using an FDA-cleared automated injection system like Max 3™.
Key benefits include:
VUEWAY® also delivers effective contrast enhancement at half the gadolinium dose of other macrocyclic GBCAs, adding another layer of patient and environmental advantage.
Over three million VUEWAY® injections have been administered across more than 900 sites, showing rapid adoption.
Gary Ray, Associate Director of MR Marketing at Bracco, summed it up clearly:
“These innovations empower hospitals to reduce waste, streamline workflow, and maintain the highest quality and sterility standards.”
The approval fits into Bracco’s broader sustainability strategy, which includes reduced gadolinium exposure, improved manufacturing efficiency, and ongoing environmental stewardship.
The Max 3™ injector is engineered for:
It supports multiple contrast media, including gadopiclenol, gadobutrol, gadobenate dimeglumine, and gadoterate meglumine, in both single-dose and bulk formats.
The system is approved for controlled contrast administration in MRI settings, with strict guidelines for sterility, disposable use, and safe operation.
VUEWAY® is approved for adults and children aged 2 years and older for MRI visualization of lesions with abnormal vascularity.
Key warnings include:
Most common side effects are headache and injection site pain (≥0.5%).
Healthcare providers must follow renal screening practices, monitor for reactions, and limit repeat dosing when possible.
Bracco Imaging is a global diagnostic imaging leader operating in more than 100 countries. The company develops contrast agents for MRI, CT, X-ray, CEUS, and molecular imaging, alongside advanced injection systems and education programs for radiology professionals.
Since 1927, Bracco has focused on innovation, precision imaging, and sustainable best practices across healthcare.