Bracco and ACIST Medical Systems have received U.S. FDA clearance on the ACIST Pro diagnostic system, an important milestone for cardiology. Bracco and its subsidiary ACIST Medical Systems confirmed FDA clearance and immediate United States launch of the ACIST Pro platform.
The companies emphasized that ACIST Pro represents a next-generation solution designed to improve diagnostic precision and procedural efficiency in catheterization laboratories. Moreover, executives highlighted that this milestone strengthens the company’s innovation strategy and expands access to advanced cardiovascular imaging technologies for clinicians nationwide.
The ACIST Pro is a variable rate contrast injection management system and allows for greater accuracy in the delivery of contrast agents through the process. Moreover, this system was developed after the ACIST CVi system, which introduced automation in contrast agent delivery in cardiac catheterization laboratories, thereby replacing manual delivery with automated, real-time precision. As such, physicians are able to achieve more accurate imaging results without compromising workflow consistency and improving patient safety in interventional cardiology procedures.
Clinical evidence supporting ACIST Pro development demonstrates measurable benefits, including an average reduction of 45 milliliters of contrast media during procedures. Furthermore, data indicate about a 30 percent decrease in contrast-induced acute kidney injury risk compared with manual injection methods. In addition, clinicians save roughly five minutes per procedure, which improves throughput and reduces the burden on busy catheterization laboratories worldwide.
In addition, the ACIST Pro enhanced workflow capabilities, as well as contrast tracking, that assists physicians in achieving individualized dosing goals. Additionally, customizable presets allow physicians to easily adjust the system for the most common procedures, making them more efficient and simplifying procedures. This means that on-screen diagnostic tools help doctors keep the system running efficiently throughout various cardiovascular procedures.
The management of the company emphasized the strategic significance of ACIST Pro in enhancing precision imaging within the contemporary healthcare environment. However, they also noted that clinician feedback guided every development stage to ensure practical usability. According to Dr. Fulvio Renoldi Bracco, ACIST Pro assists clinicians in making the transition from uncertainty to confidence during diagnostic points. In addition, according to Brad Fox, CEO of ACIST Medical Systems, the system offers both efficiency and physician safety as a unified operational standard.
The ACIST Pro system debuted in Japan in 2025, and the worldwide release of the system began before it was approved in the United States. The product subsequently received CE mark approval in accordance with the European Medical Device Regulation guidelines in February 2026 and launched in certain European countries. This FDA clearance completes an important step in expanding the availability of ACIST Pro in the major healthcare markets around the world.
Healthcare experts view ACIST Pro as part of a broader trend toward automated and data-driven technologies in interventional cardiology. Moreover, hospitals increasingly seek tools that decrease risk, improve imaging accuracy, and simplify the process without affecting the end results for patients. As a result, ACIST Pro fits into industry demands for integrated systems that incorporate both clinical performance and efficiency under pressure.
The system also assists in improvements in radiation safety, with reports showing significant reductions in user exposure when compared to previous methods. ACIST Pro is also designed to reduce setup time and make the system easier to use, which helps clinicians deal with complicated cardiovascular cases daily. This allows healthcare providers to deliver more consistent care while complying with safety and quality standards across procedures.
Bracco remains very active in research and development and considers ACIST Pro to be a significant part of its diagnostic imaging portfolio. We are committed to expanding our leadership position in contrast management technologies and helping physicians deliver excellent patient outcomes around the world. The launch of ACIST Pro is thus an example of our long-standing commitment to innovation and improved therapeutic decisions in cardiovascular medicine.
As ACIST Pro enters the United States market, hospitals and cardiologists will evaluate its performance in real-world clinical settings. However, initial signs show that the system is likely to revolutionize the practice of contrast management by providing measurable improvements in efficiency and safety. Ultimately, ACIST Pro will define the future of image-guided procedures and establish new standards for interventional cardiology globally.
