ACIST wins FDA clearance for Pro Diagnostic System

ACIST Medical Systems, a Bracco company, has received FDA clearance and launched its ACIST Pro Diagnostic System in the U.S. The system is a variable-rate contrast management platform for image-guided cardiovascular procedures.

Bracco described ACIST Pro as the next generation of its CVi automated contrast delivery technology. CVi replaced manual injection with automated, real-time contrast delivery in cardiac catheterization laboratories, according to the company.

Clinical use of CVi has been associated with an average 45 mL reduction in contrast use, a 30% reduction in contrast-induced acute kidney injury, and an average of 5 minutes saved per case, Bracco said.

Product materials list real-time contrast tracking, customizable target limits, prominent contrast utilization display, and smart detection of disposables among the platform’s features.

Setup time is 33% shorter than CVi, according to an ACIST product brochure. The company cited a faster filling syringe, new peri-pump design, flush bag, and user interface as contributors to reduced setup time.

Japan was the first launch market in 2025. Select European markets followed after the system received CE mark approval under the European Medical Device Regulation in February 2026.

ACIST is headquartered in Eden Prairie, MN. The company develops interventional and diagnostic technologies, including contrast imaging systems for cardiovascular angiography and radiology imaging.