Bracco Diagnostics gets FDA nod for CardioGen-82 infusion system

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Bracco Diagnostics, the US subsidiary of Italian diagnostic imaging company Bracco Imaging, has secured approval from the US Food and Drug Administration (FDA) for its new CardioGen-82 infusion system.

According to Bracco Diagnostics, CardioGen-82 infusion system is used for improving automation, efficiency, and simplicity in cardiac position emission tomography (PET) myocardial perfusion imaging (MPI).

CARDIOGEN-82 (Rubidium Rb 82 Generator) is a closed system which produces rubidium Rb 82 chloride injection for intravenous administration.

Rubidium Rb 82 chloride injection is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to assess regional myocardial perfusion in adults having suspected or existing coronary artery disease.

The diagnostic imaging company said that its next-generation infusion system model will replace its current infusion system.

Vittorio Puppo – President and CEO of Bracco Diagnostics 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.”

Bracco Diagnostics said that the new infusion system is designed elegantly with intuitive and ergonomic details that offer convenient access to all system components while minimizing exposure to radiation for both staff and patients.

Other smart features of the CardioGen-82 infusion system are said to help in achieving workflow efficiencies that can save approximately an hour at the start of each day of patient imaging and in removing the need for manual record keeping.

Kim McDaniel – Bracco Diagnostics Nuclear Medicine Sales and Market Support Senior Director said: “Cardiac PET MPI with the CardioGen-82 generator has helped accurately diagnose thousands of patients since 1989.

“Bracco was the first company to heavily invest in the modality for the diagnosis of coronary artery disease, and our introduction of the new infusion system is one more example of our commitment to our customers and patients worldwide.”

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