Bracco Diagnostics announces 510(k) clearance for syringeless injector

Bracco Imaging’s US unit Bracco Diagnostics and German medical device manufacturer ulrich have announced 510(k) clearance from the US Food and Drug Administration (FDA) for the rapid exchange and syringeless injector, Max 3, which is designed for magnetic resonance imaging (MRI) procedures.

Max 3 offers easy-to-manage and intuitive features, including direct injection from original contrast media vials, eliminating the need for syringe refilling.

Additionally, the absence of power cables enables flexible positioning within the MRI room, supporting a magnetic field strength of 50mT.

Its ‘Easy-Click-Cassette flex’ comes with SafeConnect, a dedicated connector for patient tubing that ensures contact protection and guards against retrograde contamination.

It can be used for up to 24 hours or with a maximum of 96 bottles of contrast media, enhancing the workflow and allowing technologists to focus more on patients during procedures.

The Max 3 injector also claims to promote environmentally sustainable practices in radiology and is expected to decrease the amount of plastic waste generated in hospitals and help manage disposal costs.

Bracco Diagnostics sales and marketing senior vice-president Cosimo De Pinto said: “Today’s clearance marks a critical step in delivering the full suite of Bracco’s robust MRI portfolio.”

Bracco Imaging CEO and vice chairman Fulvio Renoldi Bracco said: “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.

“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 signed a long-term strategic partnership with ulrich medical, aimed at introducing a Bracco-branded, MRI injector to the US market, with a focus on enhancing quality and efficiency for healthcare providers.

In October 2020, Bracco Diagnostics launched the CardioGen-82 infusion system.

“Bracco Diagnostics announces 510(k) clearance for syringeless injector” was originally created and published by Medical Device Network, a GlobalData owned brand.

The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.