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.'
Genedrive receives FDA Breakthrough Device Designation for infant hearing loss test
Mainz Biomed seeks FDA fast track for next-gen colorectal cancer test
Neuromod Devices names new general counsel
Delta-Fly Pharma initiates Phase III trial for lung cancer drug DFP-14323
Igraine plc investee Fixit Medical secures GBP270,000 Innovate UK grant
Pulnovo Medical enrols first two patients in PADN technology global multicentre clinical study
Getinge introduces CE-certified Pulsiocare for advanced hemodynamic monitoring
CND Life Sciences announces new appointments to leadership team
Tempus announces receipt of FDA clearance for AI-based AFib risk detection
bioMérieux receives FDA clearance for VITEK REVEAL AST System
CLS secures order from ClearPoint Neuro for North American launch
Bausch + Lomb to present new data at European Dry Eye Society 2024 Congress