Bracco company ACIST Medical Systems has secured U.S. Food and Drug Administration (FDA) clearance for its ACIST Pro Diagnostic System, a variable-rate contrast management platform for image-guided cardiovascular procedures.
The system is the next generation of ACIST's CVi automated contrast delivery technology. Clinical use of the 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 five minutes saved per case, according to the company.
ACIST Pro was first launched in Japan in 2025 and received the CE Mark under the European Medical Device Regulation in February 2026 before its U.S. introduction, the firm said.
