By: India Pharma Outlook Team | Friday, 24 November 2023
Bracco announced a new long-term agreement that would deliver a Bracco-branded cutting-edge MR injector to the United States under an exclusive private label agreement.
The two companies also announced the submission of a 510(k) premarket notification to the FDA for the new device manufactured by ulrich GmbH Co KG, as per pharmabiz.
In medical imaging, organ and tissue distinction is usually only achievable with the application of contrast media. Ulrich medical has been providing contrast media injectors for use in computed tomography and magnetic resonance imaging for over 30 years. The injector submitted to the FDA has already been authorized by the European Medicines Agency and is being sold in the European Union and a number of other countries around the world.
“Through our strategic collaboration and this private label agreement with ulrich medical Bracco will bring syringeless MR injectors to the US 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 US" 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 US 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".