FDA Approves Expanded Indication for Max 3™ Syringeless MR Injector from Bracco

FDA Approval of VUEWAY^® (gadopiclenol) injection Imaging Bulk Package (IBP) Enhances Options for Efficient, Sustainable MRI Contrast Delivery

PRINCETON, NJ – Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a global leader in diagnostic imaging, announced today that the U.S. Food and Drug Administration (FDA) has expanded the indication for the Bracco-branded Max 3™, a Rapid Exchange and Syringeless Injector for use in magnetic resonance imaging (MRI) procedures. In addition to single-dose and multi-dose vials, the Max 3™ system is now indicated for use with the newly approved VUEWAY^® (gadopiclenol) injection Imaging Bulk Package (IBP) in 30 mL and 50 mL formats.

The Max 3™ injector is the first and only syringeless MRI injector available on the U.S. market. It is engineered for precise, efficient, and hygienic contrast delivery. The system simplifies MRI contrast administration with intuitive, step-by-step guidance via its user interface, helping technologists perform procedures quickly, confidently, and consistently. Its flexible design accommodates both single-use vials and multi-dose IBPs, allowing hospitals to tailor contrast delivery to their workflow, patient volume, and sustainability goals.

The FDA approval of Bracco’s VUEWAY^® IBP provides a new option for hospitals seeking to improve workflow and reduce waste when using an FDA-Cleared automated contrast injection system, such as the Max 3™. With its multi-dose packaging design, VUEWAY^® IBP enables the delivery of multiple single doses of contrast from one container, ensuring aseptic handling, reduced material waste, and more efficient use of contrast agents.

VUEWAY^® (gadopiclenol) solution for injection, intravenous use provides effective contrast enhancement at half the gadolinium dose compared to other macrocyclic GBCAs for approved indications in the U.S., offering an additional layer of patient and environmental benefit.^1,2 To date, more than three million³ VUEWAY^® injections have been administered at over 902 customer sites,⁴ underscoring its growing role in high-quality MR imaging.

“This expanded presentation to our VUEWAY^® product line and the Bracco MR family of MRI solutions underscores Bracco’s ongoing commitment to advancing performance, efficiency, and sustainability in MRI contrast delivery,” said Gary Ray, Associate Director, MR Marketing, Bracco Americas. “These innovations reflect our mission to empower hospitals with flexible solutions that reduce waste, streamline workflow, and uphold the highest standards of quality and sterility across the imaging suite.”

This milestone also reinforces Bracco’s longstanding commitment to driving innovation while supporting environmental stewardship. The company has implemented sustainable manufacturing practices—including reverse osmosis and energy efficiency upgrades—and continues to develop products that reduce gadolinium exposure, plastic waste, and environmental burden.^⁵