Bracco's Syringeless MR Injector Receives FDA Approval

Nov. 25, 2025 —Bracco Diagnostics Inc. has announced 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

To learn more about VUEWAY IBP or the Max 3 injector, and how Bracco is advancing precision dosing and sustainable imaging, visit https://braccomr.com/.

¹ VUEWAY (gadopiclenol) solution for injection, intravenous use. Full Prescribing Information and Patient Medication Guide. Princeton, NJ: Bracco Diagnostics Inc.; March 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 Data on file. Three Million Doses. Bracco Diagnostics Inc.; September 2025.
⁴ Data on file. No. of Accounts. Bracco Diagnostics Inc.; September 2025.
⁵ Bracco 2024 Sustainability Report.