Acist Launches FDA-Cleared Contrast Management System in the U.S.
Acist Medical Systems, a Bracco company based in Minnesota, has received U.S. Food and Drug Administration (FDA) clearance for its Acist Pro Diagnostic System, a contrast management platform developed for use in cardiac catheterization laboratories.
Following FDA clearance, the company announced the commercial launch of the system in the United States. According to Acist, the platform has already been introduced in Europe and Japan.
The Acist Pro Diagnostic System is designed to support contrast media management during interventional cardiology procedures by providing real-time monitoring and workflow optimization tools for cath lab teams.
Real-Time Contrast Tracking and Workflow Features
According to Acist Medical Systems, the newly cleared platform includes real-time contrast tracking capabilities intended to help clinicians manage patient-specific contrast limits during procedures.
The company stated that additional workflow features include:
- Customizable procedure presets
- On-screen troubleshooting support
- Automated contrast management tools
- Workflow optimization for interventional cardiology procedures
Acist noted that the system was developed with input from clinicians working in cardiac catheterization environments.
“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,” Fox added.
Focus on Contrast Reduction and Physician Safety
According to the company, the Acist Pro Diagnostic System demonstrated reductions in contrast media usage during interventional procedures compared to previous system generations.
Acist stated that the platform offers:
- Approximately 33% faster performance than the previous model
- Up to 30% lower risk of contrast-induced acute kidney injury
- Up to 96% reduction in user radiation exposure
The company said the technology was developed to support precision imaging while helping physicians manage efficiency and safety during catheter-based procedures.
Expansion in the U.S. Market
The FDA clearance marks the latest expansion for Acist and Bracco Imaging in the interventional cardiology sector.
“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 Fulvio Renoldi Bracco, vice-chairman and 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,” Bracco added.
Source: Acist Medical Systems
