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technology22h ago
Bracco and ACIST Medical Systems Announce U.S. FDA Clearance of ACIST Pro™ Diagnostic System
- ACIST Pro Diagnostic System received U.S. FDA clearance and is launching in the United States to enhance precision in interventional cardiology.
- Bracco and ACIST say the Pro System builds on automated, real-time contrast delivery to replace manual injections.
- Prior data cited shows reduced contrast use and lower nephropathy risk with automated contrast delivery.
- The Pro System was first introduced in Japan in 2025 and later launched in Europe after CE MDR approval in February 2026.
- Bracco and ACIST position the Pro System as a standard for safe, efficient, precise contrast delivery in cath labs.
- Executives from Bracco and ACIST Herald the launch as a milestone for precision imaging in the cath lab.
- ACIST CEO Brad Fox emphasizes efficiency and safety in delivering contrast with ACIST Pro.
- ACIST Pro is part of Bracco’s broader portfolio in diagnostic imaging and contrast management.
- The system targets cardiovascular procedures, aiming to improve patient outcomes with better image guidance.
- The release notes ongoing commitment to innovation in cardiovascular imaging.
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