FDA Clears Acist Pro Diagnostic System

May 18, 2026—Acist Medical Systems, Inc., a Bracco company, announced FDA clearance and the United States launch of the Acist Pro diagnostic system, which is a next-generation variable-rate contrast management solution for image-guided cardiovascular procedures. The company stated that the system is designed for precision, safety, and efficiency.

According to Acist, the new system is the evolution of its Acist CVi automated contrast delivery technology for contrast management in cardiac catheterization laboratories. It replaces manual injection with automated, real-time precision.

The company stated that clinical use of the Acist CVi system has demonstrated outcomes compared to manual injection, including, on average, a 45-mL reduction of contrast use, a 30% reduction in contrast-induced acute kidney injury, and an average of 5 minutes saved per case.

In February 2026, Bracco and Acist announced CE Mark approval under the European Medical Device Regulation and the launch of the Acist Pro diagnostic system in Europe. The Acist Pro system was first introduced in Japan in 2025, noted the company.