Bracco Diagnostics Inc., the New Jersey-based subsidiary of Bracco Imaging S.p.A., has announced FDA clearance for the Max 3 Rapid Exchange and Syringeless Injector.

The injector, which is manufactured by Ulrich, a German manufacturer specializing in contrast media injectors and spinal implants, and distributed under separate licensing agreements with Bracco and GE HealthCare, introduces features aimed at enhancing efficiency and usability in MR workflows.

Notably, it allows direct injection from contrast media vials, eliminating the need for syringe refills. The device, free from power cables, can be positioned anywhere in MR rooms with magnetic field strengths up to 50mT.
"The basic components and functionality of MR power injectors have not changed in decades in the U.S.," Noelle M. Heber, senior director of MR and X-ray contrast media at Bracco Diagnostics, told HCB News. "Max 3 is a major disruptor to how contrast and saline will be injected in the MR suite. With the elimination of syringes, the precision dosing of saline and contrast, and the improvements in workflow, this system will not only help customers work more efficiently, but also provide the first sustainable breakthrough in MR injectors."

Max 3 utilizes an Easy-Click-Cassette flex system incorporates SafeConnect technology, which protects against retrograde contamination and supports use for up to 24 hours or 96 contrast media bottles. The design is also geared toward sustainability, potentially reducing plastic waste and operational costs in radiology departments.

"If you add the sustainability of the Max 3 system to our VUEWAY (gadopiclenol) gadolinium-based contrast agent (GBCA), which provides effective contrast enhancement at half the gadolinium dose compared to other macrocyclic GBCAs for approved indications in the U.S., you’ve really taken significant strides forward for both the patient and the Earth," said Heber.

Bracco Imaging operates globally, delivering solutions across diagnostic imaging modalities, including X-ray, ultrasound, and nuclear medicine. With R&D centers in the U.S., Europe, and a workforce of 3,600 employees.

“We’re thrilled to bring an intuitive, easy-to-use, and environmentally friendly solution to the radiology community in collaboration with Bracco," said Klaus Kiesel, CEO of ulrich medical.

When asked about a similar syringeless system for CT injection, Heber referenced Bracco's CT Express Evo, which is not currently available in the U.S.

For GE, the MR Max 3 is the second syringeless power injector solution, following the launch of the CT Motion injector at RSNA in 2022, which is also licensed via Ulrich.

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