Bracco and ACIST Medical Systems Launch Next-Generation ACIST Pro Diagnostic System in Europe
核心洞察
ACIST Medical Systems (搜索), a Bracco Group (搜索) company, has launched the ACIST Pro Diagnostic System (搜索) in selected European markets following CE Mark approval under the European Medical Device Regulation.
The next-generation variable-rate contrast management system builds on the proven ACIST CVi (搜索) technology, which has demonstrated a 45ml reduction in contrast use and 30% reduction in contrast-induced acute kidney injury (搜索).
The system was first introduced in Japan in 2025, with additional global availability expected throughout 2026 and FDA 510(k) clearance pending in the United States.
ACIST Medical Systems (搜索), Inc., a Bracco Group (搜索) company and global leader in advanced contrast management technologies, has announced the European launch of the ACIST Pro Diagnostic System (搜索), a next-generation variable-rate contrast management solution designed to enhance precision, safety, and efficiency in image-guided cardiovascular procedures.
The system received CE Mark approval under the European Medical Device Regulation (MDR), confirming compliance with applicable EU safety, health, and environmental protection standards. The launch represents a significant advancement in automated contrast delivery technology for cardiac catheterization laboratories.
Clinical Benefits Demonstrated
The ACIST Pro system builds upon the established ACIST CVi (搜索) automated contrast delivery technology, which has demonstrated substantial clinical benefits compared to manual injection methods. Clinical use of the predecessor ACIST CVi system has shown an average 45ml reduction in contrast use, a 30 percent reduction in contrast-induced acute kidney injury (搜索) (CI-AKI), and an average of five minutes saved per case.
"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 (搜索). "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."
Technology Evolution
The ACIST Pro system represents the evolution of ACIST's automated contrast delivery technology, which revolutionized cardiac catheterization laboratory contrast management by replacing manual injection with automated, real-time precision. The new system is designed to advance precision and efficiency in cardiac catheterization laboratories while maintaining the proven benefits of its predecessor.
Brad Fox, CEO of ACIST Medical Systems (搜索), emphasized the system's advancement: "Building on the trusted ACIST CVi (搜索) 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."
Global Rollout Strategy
The ACIST Pro system was first introduced in Japan in 2025, marking the beginning of its global availability. Additional international markets are expected to receive access throughout 2026. In the United States, FDA 510(k) clearance remains pending, with regulatory approval anticipated to enable broader market access.
The European launch continues Bracco and ACIST Medical Systems (搜索)' shared mission of delivering practical solutions that support precision, safety, and performance across interventional cardiology, radiology, and vascular care.
Company Background
Bracco Group (搜索), founded in 1927, operates in the healthcare sector across more than 100 countries and is recognized as a global leader in diagnostic imaging. The company employs over 3,800 people and generates consolidated annual revenues of approximately €2 billion, with 88% derived from international markets. Bracco demonstrates strong commitment to innovation by investing around 9% of its reference turnover in Research & Development, primarily focused on imaging diagnostics and medical devices. The Group holds more than 2,000 active patents worldwide.
ACIST Medical Systems (搜索) 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. As a global market leader in advanced contrast imaging systems for cardiovascular angiography and radiology imaging, ACIST is committed to bringing innovative technologies that simplify cardiovascular procedures and empower clinicians to provide superior patient care.