Bracco and ACIST Medical Systems Announce U.S. FDA Clearance of ACIST Pro™ Diagnostic System

May 18, 2026 |

5 min read

Next-generation system delivers precise contrast control to streamline interventional cardiology procedures

MILAN, May 18, 2026 /PRNewswire/ -- ACIST Medical Systems, Inc., a Bracco company and a global leader in advanced contrast management technologies, today announced 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 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

"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 https://www.bracco.com/.

See the instructions for use for complete indications and safety information for the ACIST Pro^™ Diagnostic System.

ACIST Pro is a trademark of ACIST Medical Systems, Inc.

ACIST Medical Systems, Inc. reserves the right to modify the specifications and features described herein or discontinue manufacture of the products described at any time without prior notice or obligation. Please contact your authorized ACIST sales representative for the most current information.

About Bracco

Bracco group, founded in 1927, is a global leader in diagnostic imaging, committed to advancing healthcare and improving people's lives by shaping the future of prevention and precision medicine.

The company operates in the healthcare sector across more than 100 countries, with a workforce of over 4,000 employees and consolidated annual revenues of approximately €2 billion, 88% of which are generated by international markets.

With a strong commitment to innovation - investing around 9% of its reference turnover in Research & Development - Bracco develops and provides a broad portfolio of pharmaceutical products for diagnostic imaging: contrast agents for X-ray, Computed Tomography (CT), and Magnetic Resonance Imaging (MRI), as well as microbubbles for Contrast Enhanced Ultrasound (CEUS), and Molecular Imaging through radioactive tracers and novel PET imaging agents, alongside AI-based solutions. It is also a global market leader in advanced contrast management technologies for cardiovascular angiography and radiology imaging.

Discover more at www.bracco.com.

About ACIST Medical Systems

ACIST Medical Systems, Inc. is an interventional and diagnostic technology company with a portfolio of advanced products, including the world's first Rapid Exchange FFR and High Definition IVUS systems. It is also a global market leader in advanced contrast imaging systems for cardiovascular angiography and radiology imaging. Through these products, ACIST is demonstrating its commitment to bringing unique and innovative technologies that simplify cardiovascular procedures and empower clinicians to treat patients with superior care. As part of the Bracco Group, ACIST benefits from the resources of a multinational conglomerate with broad expertise in cath lab technology and a dedication to continuous advancement. Headquartered in Eden Prairie, Minnesota, USA, ACIST has a worldwide presence with over 300 direct employees and facilities in Silicon Valley, Heerlen, and Tokyo. To learn more about ACIST, visit www.acist.com.

Media Contacts:

Bracco Press Contact:

Alessandra Vulpiani

Bracco Imaging, Senior Marketing Communications Manager

Alessandra.vulpiani@bracco.com

ACIST Medical Systems Press Contact:

Angela Boner

ACIST, Marketing Communications Manager

Angela.boner@acistmedical.com

References

¹Minsinger 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.