Bracco gains FDA approval for new cardiac PET infusion system

Bracco Diagnostics has received U.S. Food and Drug Administration approval for its new cardiac PET myocardial perfusion imaging system, the company announced on Oct. 16.

The CardioGen-82 infusion system is a closed system used to produce rubidium-82 chloride injection for intravenous administration. It was developed with nuclear medicine providers in mind, affording easier access to all components while also minimizing their radiation exposure.

“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,” President and CEO of Bracco Imaging’s U.S. subsidiary, Vittorio Puppo, said in a statement. “Developing innovative products that support clinicians in diagnosing coronary artery disease is our commitment to the patients we serve.”

This update will replace the company’s existing infusion system and includes new smart features, such as workflow improvements and dosing options to save clinicians an hour at the start of each day, the company said.