Acist Medical Systems has announced the launch in selected European markets of the Acist Pro diagnostic system, a 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 latest generation of Acist’s automated contrast delivery technology, Acist CVi, which replaces manual injection with automated, real-time precision.
“The launch of Acist Pro is an important step in our ongoing effort to advance precision imaging across specialties,” said Fulvio Renoldi Bracco, chief executive officer 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 catheterisation 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, chief executive officer of Acist Medical Systems.
The Acist Pro system was first introduced in Japan in 2025. Additional global availability is expected throughout 2026. US Food and Drug Administration (FDA) 510(k) clearance is pending in the USA.
