The private label arrangement will bring a new syringeless magnetic resonance (MR) injector to the U.S. 510(k) premarket notification has been submitted to the U.S. Food and Drug Administration
Bracco, a global leader in diagnostic imaging, and ulrich GmbH & Co. KG, a renowned German medical device manufacturer specializing in contrast media injectors and spinal implants, announced today a new long-term partnership that will bring a Bracco-branded, state-of-the-art MR injector to the United States under an exclusive private label arrangement. The two companies also announce the submittal of a 510(k) premarket notification to the FDA for the new device manufactured by ulrich GmbH & Co. KG.
Organ and tissue differentiation is frequently only possible with the use of contrast media in medical imaging. For over 30 years, ulrich medical has offered contrast media injectors for use in computed tomography and magnetic resonance imaging. The injector submitted to the FDA is already approved by the European Medicines Agency and commercialized by ulrich medical in the European Union and in numerous other countries around the globe.
"Through our strategic collaboration and this private label agreement with ulrich medical, Bracco will bring syringeless MR injectors to the U.S. and today's 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."
"This strategic collaboration with Bracco Imaging to introduce this contrast media injector to the U.S. market represents our commitment to innovation and excellence in healthcare," said Klaus Kiesel, Chief Executive Officer of ulrich medical. "Together, we look forward to setting the new standard for patient care in MR."
