Acist Medical Systems, a Bracco company, recently announced US Food and Drug Administration (FDA) clearance of the Acist Pro diagnostic system, a next-generation variable-rate contrast management solution for image-guided cardiovascular procedures.
Acist Pro is the evolution of Acist’s automated contrast delivery technology, Acist CVi, which the company notes “revolutionised” cardiac catheterisation laboratory contrast management by replacing manual injection with automated, real-time precision. Clinical use of the Acist CVi system has demonstrated outcomes comparable to manual injection, including on average a 45ml reduction in contrast use, a 30% reduction in contrast-induced acute kidney injury (CI-AKI), and an average of five minutes saved per case.
“Expanding access to the Acist Pro system in the United States marks an important milestone for our company and for the future of precision imaging in the cath lab,” said Fulvio Renoldi Bracco, vice chairman and CEO of Bracco Imaging. “By helping clinicians move from uncertainty to confidence at the point of diagnosis, we are supporting more informed decisions with the goal of improving patient outcomes. We are proud to introduce this solution to the US market and look forward to the positive impact it will have.”
“Clinicians have guided the development of the Acist Pro diagnostic system every step of the way, reinforcing the need to bring efficiency and physician safety together as a single standard,” said Brad Fox, CEO of Acist Medical Systems. “Designed for precise delivery of contrast media in interventional cardiology, the system streamlines cath lab procedures with consistently clear images. Bringing [the] Acist Pro system to the United States reflects our continued commitment to innovation and to supporting the teams who rely on this technology every day.”
A press release notes that the Acist Pro system was first introduced in Japan in 2025 and subsequently launched in select European markets after earning CE mark approval under the European Medical Device Regulation (MDR) in February 2026.
