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August 7, 2026

SMARTFLOW Study of AngioInsight’s AngioAI+ Software Platform Begins Enrollment

KEY TAKEAWAYS

  • AngioInsight’s SMARTFLOW study enrolled its first patient and is expected to include approximately 600 patients at 17 United States and European centers.
  • The study will evaluate the investigational AngioAI+ platform for angiography-derived fractional flow reserve and detection of coronary microvascular disease.
  • SMARTFLOW will compare the software’s diagnostic performance with established invasive physiologic reference standards.

August 7, 2026—AngioInsight Inc., a developer of artificial intelligence (AI)–powered cardiovascular diagnostics, announced the enrollment of the first patient in the SMARTFLOW clinical study of the company’s investigational AngioAI+ software platform.

According to AngioInsight, SMARTFLOW is the company’s first prospective, multicenter clinical study evaluating the performance of AngioAI+. It is expected to enroll approximately 600 patients across 17 leading cardiovascular centers in the United States and Europe.

The study aims to evaluate the diagnostic performance of AngioAI+ for providing angiography-derived fractional flow reserve and detection of coronary microvascular disease. SMARTFLOW incorporates established invasive physiologic reference standards as benchmarks for success, noted the company.

AngioInsight stated that the Angio+ platform is being developed to assess coronary physiology, including anatomic and functional parameters from routine coronary angiographic images without requiring additional invasive instrumentation or procedural workflow changes. The platform is intended to integrate into existing catheterization laboratory workflows to support physician evaluation during diagnostic and interventional coronary procedures.

The study is led by Coprincipal Investigators, cardiologists Carlos Collet, MD, and Todd C. Villines, MD. Dr. Collet is from the Cardiovascular Research Foundation (CRF) and Columbia University in New York, New York. Dr. Villines is from the University of Virginia in Charlottesville, Virginia. The study is being conducted in collaboration with CRF.

The first patient in the SMARTFLOW study was enrolled by Yader Sandoval, MD, and his research team at the Minneapolis Heart Institute Foundation at Allina Health Minneapolis Heart Institute, Abbott Northwestern Hospital in Minneapolis, Minnesota.

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