FDA Expands Max 3™ Syringeless MRI Injector for Use with VUEWAY® Imaging Bulk Package
核心洞察
The FDA has expanded the indication for Bracco's Max 3™ syringeless MRI injector to include use with VUEWAY® (gadopiclenol) injection Imaging Bulk Package in 30 mL and 50 mL formats.
The Max 3™ is the first and only syringeless MRI injector available in the U.S. market, designed for precise, efficient, and hygienic contrast delivery.
VUEWAY® provides effective contrast enhancement at half the gadolinium dose compared to other macrocyclic GBCAs, with over three million injections administered at more than 902 customer sites.
Bracco Diagnostics Inc. announced that the U.S. Food and Drug Administration has expanded the indication for the company's Max 3™ syringeless MRI injector to include use with the newly approved VUEWAY® (gadopiclenol) injection Imaging Bulk Package (IBP) in 30 mL and 50 mL formats. The approval enhances options for efficient and sustainable MRI contrast delivery in clinical settings.
First-in-Class Syringeless Technology
The Max 3™ injector represents a significant advancement in MRI contrast delivery as the first and only syringeless MRI injector available on the U.S. market. The system is engineered for precise, efficient, and hygienic contrast delivery, featuring intuitive step-by-step guidance through its user interface to help technologists perform procedures quickly, confidently, and consistently.
The flexible design accommodates both single-use vials and multi-dose IBPs, allowing hospitals to tailor contrast delivery to their specific workflow requirements, patient volume, and sustainability goals. This versatility addresses varying operational needs across different healthcare facilities.
Enhanced Workflow and Sustainability Benefits
The FDA approval of VUEWAY® IBP provides hospitals with new options for improving workflow and reducing waste when using FDA-cleared automated contrast injection systems. The multi-dose packaging design enables the delivery of multiple single doses of contrast from one container while ensuring aseptic handling, reduced material waste, and more efficient use of contrast agents.
VUEWAY® (gadopiclenol) solution for injection provides effective contrast enhancement at half the gadolinium dose compared to other macrocyclic GBCAs for approved indications in the U.S., offering additional patient and environmental benefits. To date, more than three million VUEWAY® injections have been administered at over 902 customer sites, demonstrating its growing adoption in high-quality MR imaging.
Clinical Applications and Safety Profile
VUEWAY® injection is indicated in adults and children aged 2 years and older for use with magnetic resonance imaging to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine, and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).
The contrast agent carries important safety considerations, including warnings about nephrogenic systemic fibrosis (搜索) risk in patients with impaired kidney function and contraindications for intrathecal use. The most common adverse reactions with an incidence ≥ 0.5% are injection site pain (0.7%) and headache (0.7%).
Industry Impact and Future Outlook
"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."
The milestone reinforces Bracco's commitment to environmental stewardship through sustainable manufacturing practices, including reverse osmosis and energy efficiency upgrades, while continuing to develop products that reduce gadolinium exposure, plastic waste, and environmental burden.