Ulrich & Co, a German-based medical device manufacturer of contrast media injectors and spinal implants, and Bracco Imaging, a multinational life science company and a specialist in diagnostic imaging, have signed an agreement to distribute a Bracco branded MRI injector manufactured by Ulrich Medical in the U.S. market.
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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).
Cornelia Schweizer, vice president global sales & marketing, said: "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.”
Klaus Kiesel, chief executive officer of Ulrich Medical, commented: "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.”
Fulvio Renoldi Bracco, vice chairman & chief executive officer of Bracco Imaging, added: “Through our strategic collaboration and this private label agreement with Ulrich Medical, Bracco will bring syringeless MRI 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. 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."
