ACIST Medical Systems Launches ACIST Pro Diagnostic System in Europe

Feb. 12, 2026 — ACIST Medical Systems, Inc., a Bracco Group company, has announced the launch in selected markets in Europe 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.

The CE Mark was granted under the European Medical Device Regulation (MDR), which confirms compliance with applicable EU safety, health, and environmental protection standards. ACIST Pro is the evolution of ACIST’s automated contrast delivery technology, ACIST CVi, which revolutionized cardiac catheterization laboratory contrast management by replacing manual injection with automated, real-time precision. Clinical use of the ACIST CVi system has demonstrated outcomes compared to manual injection, including on average 45ml reduction of contrast use¹, a 30 percent reduction in CI-AKI^1,2, and an average of five minutes saved per case.³

“The launch of ACIST Pro is an important step in our ongoing effort to advance precision imaging across specialties,” said Dr. Fulvio Renoldi Bracco, CEO of Bracco Imaging. “By thoughtfully evolving a trusted platform, we are responding to the real-world needs of today’s interventional teams. This milestone reflects our commitment to delivering practical, forward-looking solutions that support quality, safety, and sustainability in diagnostic imaging.”

“Building on the trusted ACIST CVi system, ACIST Pro is our next-generation solution, enhancing precision and efficiency in the cardiac catheterization laboratory. With its European launch, we are proud to bring this advanced technology to clinicians and continue our commitment to innovation in interventional imaging,” said Brad Fox, CEO of ACIST Medical Systems.

With this European launch, Bracco and ACIST Medical Systems continue to advance their shared mission of delivering practical solutions that support precision, safety, and performance across interventional cardiology, radiology, and vascular care.

The ACIST Pro system was first introduced in Japan in 2025. Additional global availability is expected throughout 2026. FDA 510(k) clearance is pending in the United States.  For more information about the ACIST Pro System, visit acist.com/acist-pro.

For additional information about Bracco’s products, and for full prescribing information, please visit https://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.