Therapy Areas: Devices
Bracco signs long-term partnership with ulrich GmbH
23 November 2023 -

Bracco, an Italy-based company that deals with diagnostic imaging, announced on Wednesday that it entered into a new long-term partnership with ulrich GmbH & Co. KG, a Germany-based medical device manufacturer specialising in contrast media injectors and spinal implants.

The collaboration is intended to bring a Bracco-branded MR injector to the United States under an exclusive private label arrangement. Both companies have also submitted a 510(k) premarket notification to the FDA for the new device manufactured by ulrich GmbH & Co. KG.

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.

Fulvio Renoldi Bracco Imaging SpA, vice chairman & chief executive Officer, said, '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. 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.'