Bracco, ACIST Medical Systems Receive FDA Clearance of ACIST Pro Diagnostic System

May 18, 2026 — ACIST Medical Systems, a Bracco company, has received U.S. Food and Drug Administration (FDA) clearance and U.S. launch of the ACIST Pro Diagnostic System, a next-generation variable-rate contrast management solution designed to advance precision, safety and efficiency in image-guided cardiovascular procedures.

ACIST Pro is the evolution of ACIST's automated contrast delivery technology, ACIST CVi, which replaced manual injection with automated, real-time precision. Clinical use of the ACIST CVi system has demonstrated outcomes compared to manual injection, including on average 45 ml reduction of contrast use¹, a 30 percent reduction in CI-AKI^1,2, and an average of five minutes saved per case.³

"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 Dr. Fulvio Renoldi Bracco, vice-chairman/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 U.S. 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 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."

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. For additional details about the ACIST Pro System, visit acist.com/acist-pro/.

For additional information about Bracco's products and for full prescribing information, please visit www.bracco.com/.

References

1. Minsinger KD, Kassis HM, Block CA, Sidhu M, Brown JR (2014) Meta-analysis of the effect of automated contrast injection devices versus manual injection and contrast volume on risk of contrast-induced nephropathy. Am J Cardiol 113 (1): 49-53.

2. Call J, Sacrinty M, Applegate R, Little W, Santos R et al. (2006) Automated contrast injection in contemporary practice during cardiac catheterization and PCI: effects on contrast-induced nephropathy. J Invasive Cardiol 18 (10): 469-474.

3. Lehmann C, Hotaling M (2005) Saving time, saving money: a time and motion study with contrast management systems. J Invasive Cardiol 17 (2): 118-121.