Bracco Diagnostics Inc. Branded Max 3™ received FDA 510(k) clearance

Bracco Diagnostics Inc. Branded Max 3^TM, a Rapid Exchange and Syringeless Injector, received FDA 510(k) clearance adding evolving innovation in Magnetic Resonance Imaging (MRI) and its product portfolio

With this clearance, Bracco sets a new standard for patient care in Magnetic Resonance Imaging (MRI)

PRINCETON, NJ – Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, along with ulrich GmbH & Co. KG, a renowned German medical device manufacturer specializing in contrast media injectors and spinal implants, announced today the clearance of the Bracco branded Max 3^TM, a Rapid Exchange and Syringeless Injector for use in magnetic resonance imaging (MRI) procedures.

The Max 3^TM is a first of its kind in the MRI space. The innovative injector offers intuitive, efficient, and easy-to-manage features such as direct injection from original contrast media vials meaning no need for refilling of syringes, and no power cables so it can be positioned anywhere in the MRI room up to a maximum magnetic field strength of 50mT. The Easy-Click-Cassette flex has a dedicated connector to the patient tubing with SafeConnect, providing contact protection and reliable protection against retrograde contamination which can be used within 24 hours or up to a maximum of 96 bottles of contrast media, or whichever comes first, thus improving workflow for the technologist, allowing more time to focus on the patient during a procedure.

In addition to being easy to use, the Max 3^TM injector supports best practices in radiology sustainability. This injector will strengthen green efforts in radiology suites because it will contribute less plastic to a hospital's disposable process and costs.

“This clearance underscores Bracco’s commitment to pushing the boundaries of innovation in 2024 and beyond while implementing sustainable production in all aspects of our business model,” said Fulvio Renoldi Bracco, Vice Chairman & Chief Executive Officer of Bracco Imaging S.p.A. “At Bracco, we always strive for advancements, and it’s remarkable to see how innovative diagnostic imaging solutions have transformed the MRI industry. Each step gets us closer to redefining the standard of patient care to meet today’s clinical needs.” In November 2023, Bracco announced a long-term strategic partnership with ulrich medical to bring a Bracco-branded, state-of-the-art MRI injector to the U.S. with a commitment to improved quality and efficiency for healthcare providers.

“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, Chief Executive Officer of ulrich medical. “Together, we’re taking MRI innovation to the next level in healthcare.”

“Today’s clearance marks a critical step in delivering the full suite of Bracco’s robust MRI portfolio,” said Cosimo De Pinto, Senior Vice President of Sales and Marketing, Bracco Diagnostics Inc. “We are proud to be a trusted partner of choice for the radiology community in need of MRI solutions that will help them determine the best course of treatment for their patients.”

The Max 3^TM Injector’s innovative design earned it a Red Dot Design Award, an international design competition for product design, communication design, and design concepts.

Click here to see the features of the Max 3^TM Injector.