The Max 3 MRI injector from ulrich medical, which will be distributed under the Bracco brand in the U.S. (510(k) pending).
Ulm, 21. November 2023. ulrich GmbH & Co. KG, a German-based medical device manufacturer of contrast media injectors and spinal implants, and Bracco Imaging S.p.A., a multinational life science company and a global leader in diagnostic imaging, have signed a Bracco branded state-of-the art MRI injectors manufactured by ulrich medical in the U.S. market.
Therefore, ulrich medical has submitted a premarket notification 510(k) to the U.S. Food and Drug Administration (FDA) for its syringeless contrast media injector for magnetic resonance imaging (MRI).
“The strong brand of Bracco helps us to market our MRI injectors in the U.S. while ulrich medical remains the legal manufacturer of the devices,” says Cornelia Schweizer, Vice President Global Sales & Marketing.
“We are delighted to be working with Bracco Imaging S.p.A. With Bracco’s nationwide brand recognition we will enter with our MRI injector technology the largest medical market in the world,” Klaus Kiesel, Chief Executive Officer of ulrich medical, comments on the agreement.
“Through our strategic collaboration and this private label agreement with ulrich medical Bracco will bring syringeless MR injectors to the U.S. and the submission for 510(k) clearance to the FDA brings us one step closer to elevating the standard of diagnostic imaging solutions around the country to expand Bracco’s MR portfolio in the U.S.,” said Fulvio Renoldi Bracco, Vice Chairman & Chief Executive Officer of Bracco Imaging S.p.A. “We are taking bold actions to help make a difference for patients, and this long term partnership serves as a testament to our commitment to improved quality and efficiency for healthcare providers.”
For more information, visit https://www.ulrichmedical.com.
About ulrich medical
ulrich GmbH & Co. KG, ulrich medical for short, develops, produces and distributes contrast media injectors and spinal systems. The family-owned company, founded in 1912, employs a total of over 500 people at its headquarters in Ulm and its two subsidiaries in France and the USA. While the products are used worldwide, the medical technology company focuses on “Made in Germany” quality, making it one of the few in the industry that consistently develops and manufactures its products in Germany. The F.A.Z. Institute named ulrich medical 2023 one of Germany’s “Innovation Leaders” for the fifth time in a row.