CardioGen-82, a closed system, will enable to produce rubidium Rb 82 chloride injection for intravenous administration
The US FDA’s Centre for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)
Bracco Imaging’s US subsidiary Bracco Diagnostics has secured approval from the US Food and Drug Administration (FDA) for its new CardioGen-82 (Rubidium Rb 82 Generator) infusion system.
The new CardioGen-82 infusion system has been developed to improve automation, efficiency and simplicity in cardiac position emission tomography (PET) myocardial perfusion imaging (MPI).
Designed to replace the firm’s current infusion system, the next-generation infusion system will facilitate easy access to all system components, while reducing the radiation exposure for staff and patients.
The new system also enables the improvement of workflow efficiencies by saving an hour at the starting of each day of patient imaging and avoiding manual record keeping.
CardioGen-82 is a closed system that will help produce rubidium Rb 82 chloride injection for intravenous administration.
CardioGen-82 is manufactured by GE Healthcare and Medi-Physics
Rubidium Rb 82 chloride injection is a radioactive diagnostic agent that will allow positron emission tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to assess regional myocardial perfusion in adult patients with suspected or existing coronary artery disease.
GE Healthcare and Medi-Physics are manufacturing the CardioGen-82 infusion system for Bracco Imaging, which is a registered trademark of Bracco Diagnostics.
Bracco Diagnostics president and CEO Vittorio Puppo said: “The new infusion system exemplifies Bracco’s significant investment in the cardiac PET imaging modality and is the culmination of thoughtful design and feedback from healthcare providers.
“Developing innovative products that support clinicians in diagnosing coronary artery disease is our commitment to the patients we serve.”
In June 2019, Bracco Imaging agreed to acquire UK-based molecular imaging company Blue Earth Diagnostics from Syncona for an equity value of around $450m (£354.7m).
Bracco Imaging provides a product and solution portfolio for all major diagnostic imaging modalities, including X-ray imaging, magnetic resonance imaging (MRI), contrast enhanced ultrasound (CEUS), and nuclear medicine through radioactive tracers and novel PET imaging agents.