FDA Clears Bracco's Advanced ACIST Pro Diagnostic System for U.S. Market

The ACIST Pro™ Diagnostic System, a cutting-edge development in variable-rate contrast management, has received clearance from the U.S. Food and Drug Administration (FDA), as announced by ACIST Medical Systems, a part of the Bracco Group. This next-generation system is designed to enhance precision, safety, and efficiency in image-guided cardiovascular procedures, marking a significant advancement in interventional cardiology.

Building on the established ACIST CVi® system, the ACIST Pro™ system further refines contrast management by automating what has traditionally been a manual process. The ACIST CVi® has already demonstrated significant clinical benefits, including an average reduction of 45 mL in contrast use, a 30% decrease in contrast-induced acute kidney injury (CI-AKI), and time savings of approximately 5 minutes per procedure.

Dr. Fulvio Renoldi Bracco, Vice-Chairman & CEO of Bracco Imaging, emphasized the importance of this advancement, stating that the launch of ACIST Pro™ in the United States is a pivotal milestone for precision imaging in cardiac catheterization laboratories. By facilitating better-informed decision-making, the system aims to improve patient outcomes in interventional procedures.

Brad Fox, CEO of ACIST Medical Systems, highlighted the collaborative efforts of clinicians in the development of this system, stressing the focus on advancing both procedural efficiency and physician safety. The ACIST Pro™ System’s introduction in the United States reflects the company's ongoing dedication to innovation in contrast media delivery and imaging clarity.

Initially unveiled in Japan in 2025, the ACIST Pro™ system was subsequently launched in select European markets after obtaining CE mark approval under the European Medical Device Regulation (MDR) in early 2026.