Bracco's Max 3 Syringeless MR Injector Receives FDA Expansion Approval

In a significant advancement in the field of medical imaging, Bracco Diagnostics Inc. has announced that the U.S. Food and Drug Administration (FDA) has expanded the indications for its innovative Max 3™ Syringeless MR Injector. This approval allows the injector to be utilized in conjunction with the newly approved VUEWAY® (gadopiclenol) injection, a device that supports efficient delivery for MRI procedures. With this development, healthcare facilities gain a greater ability to streamline imaging processes while minimizing waste.

The Max 3™ injector stands out as the first and only syringeless MRI injection system currently available in the U.S. market. Its unique design promotes precision, efficiency, and hygienic operation, facilitating a faster and more consistent contrast media administration. Notably, the user-friendly interface provides step-by-step guidance, empowering healthcare providers to execute MRI procedures with confidence and speed.

The latest FDA approval adds versatility to the Max 3™ injector by allowing it to accommodate both standard single-dose vials and the new multi-dose VUEWAY® Imaging Bulk Package (IBP) in 30 mL and 50 mL formats. This dual capability not only enhances workflow but also aligns with sustainability goals in many healthcare settings. The multi-dose packaging reduces the amount of handling and potential waste, making it a compelling option for hospitals focused on sustainability while still delivering high-quality patient care.

According to Bracco's Associate Director of MR Marketing, Gary Ray, this expansion reflects the company's ongoing commitment to improving MRI contrast delivery. “These innovations are intended to help hospitals reduce material waste and streamline workflows while maintaining the highest standards of quality and sterility,” said Ray.

What is equally important is the approval of VUEWAY® (gadopiclenol) for intravenous use, which provides effective contrast enhancement at reduced gadolinium doses compared to traditional macrocyclic gadolinium-based contrast agents (GBCAs). This factor emphasizes the dual benefit of patient safety and environmental concern, reducing both health risks and waste in medical facilities. VUEWAY® has already seen widespread usage, with over three million injections administered across various healthcare sites.

The design and implementation of sustainable manufacturing practices at Bracco further underscore the company's pledge to innovation while being environmentally conscious. Bracco's initiatives aim to reduce the environmental footprint by diminishing gadolinium exposure and minimizing plastic waste, a growing concern in modern healthcare.

In summary, Bracco Diagnostics is not just enhancing the efficiency of MRI procedures through its Max 3™ injector and VUEWAY® IBP; it is also setting new benchmarks for sustainability and patient safety in medical imaging environments. As Bracco continues to push the boundaries of technological innovation and environmental stewardship, the healthcare landscape is poised for a positive transformation, benefiting both patients and medical practitioners alike.

For more information on the Max 3™ injector and VUEWAY®, visit Bracco's dedicated MRI website.