AngioInsight™ Enrolls First Patient in SMARTFLOW™ Clinical Study to Advance AI-Powered Coronary Diagnostics
AngioInsight Inc., a medical technology company focused on developing artificial intelligence (AI)-driven cardiovascular diagnostic solutions, has announced the enrollment of the first patient in its SMARTFLOW™ clinical study, marking a major milestone in the company’s efforts to transform the assessment of coronary artery disease using advanced AI technologies.
The first patient enrollment officially launches the prospective, multicenter clinical investigation evaluating AngioAI+™, AngioInsight’s investigational software platform designed to analyze routine coronary angiographic images and generate comprehensive physiologic assessments of coronary circulation. The study represents the company’s first large-scale prospective clinical evaluation and is expected to generate critical evidence supporting future regulatory submissions while advancing the role of artificial intelligence in cardiovascular diagnostics.
By combining expertise from internationally recognized cardiologists, leading cardiovascular research institutions, and experienced clinical research organizations, SMARTFLOW aims to demonstrate how AI-powered image analysis can improve the diagnosis of both obstructive coronary artery disease and coronary microvascular disease using standard coronary angiography.
A Significant Milestone for AngioInsight
The enrollment of the first participant represents more than the beginning of a clinical trial—it reflects years of scientific research, engineering development, algorithm refinement, and collaboration between physicians, biomedical engineers, clinical investigators, and regulatory experts.
AngioInsight developed AngioAI+™ with the goal of enabling physicians to extract significantly more physiologic information from conventional coronary angiograms without requiring additional invasive procedures or complex image manipulation.
As cardiovascular disease remains the leading cause of death worldwide, clinicians continue searching for technologies that improve diagnostic accuracy while simplifying workflow and expanding patient access to advanced physiologic testing.
SMARTFLOW has been designed to evaluate whether artificial intelligence can help meet these objectives by providing automated physiologic assessments directly from angiographic images already acquired during routine cardiac catheterization.
Evaluating AngioAI+™ in a Prospective Clinical Study
SMARTFLOW™ is a prospective, multicenter clinical study that will evaluate the diagnostic performance of AngioAI+™ in real-world clinical practice across multiple cardiovascular centers.
Unlike retrospective analyses that evaluate previously collected data, prospective studies enroll patients before outcomes are known, allowing researchers to rigorously assess performance under routine clinical conditions.
The multicenter design also enables investigators to evaluate software performance across diverse patient populations, healthcare systems, physicians, and imaging environments, helping strengthen the scientific validity of the study findings.
Through this clinical investigation, AngioInsight hopes to establish robust evidence demonstrating the ability of AngioAI+™ to generate clinically meaningful physiologic information from standard coronary angiographic images.
Focus on Coronary Physiology
Coronary artery disease remains one of the most common cardiovascular conditions globally, affecting millions of individuals each year.
Although coronary angiography has long served as the standard imaging technique for visualizing coronary artery anatomy, anatomical narrowing alone does not always determine whether reduced blood flow is clinically significant.
For this reason, physicians increasingly rely on physiologic measurements that assess how coronary lesions affect blood flow to the heart muscle.
SMARTFLOW is specifically designed to evaluate how artificial intelligence may improve these physiologic assessments while reducing procedural complexity.
Rather than relying solely on visual interpretation of coronary narrowing, AngioAI+™ seeks to provide functional information that supports more informed clinical decision-making.
Measuring Angiography-Derived Fractional Flow Reserve
One of the primary objectives of SMARTFLOW is evaluating AngioAI+’s ability to provide angiography-derived fractional flow reserve (FFR).
Fractional flow reserve is an established physiologic measurement used to determine whether a coronary artery narrowing significantly restricts blood flow and requires intervention.
Traditionally, invasive FFR measurement requires the placement of a specialized pressure wire inside the coronary artery while medications induce maximal blood flow.
Although highly effective, invasive FFR increases procedural complexity, requires additional equipment, and may not be performed in every patient undergoing coronary angiography.
AngioAI+™ seeks to estimate FFR directly from routine angiographic images using advanced artificial intelligence algorithms.
If successfully validated, this capability could simplify physiologic assessment by reducing dependence on additional invasive measurements while maintaining clinically useful information.
Addressing Coronary Microvascular Disease
In addition to angiography-derived FFR, SMARTFLOW will evaluate the software’s ability to detect coronary microvascular disease (CMD).
Unlike obstructive coronary artery disease involving large coronary arteries, coronary microvascular disease affects the heart’s smaller blood vessels, which are often difficult to evaluate using conventional imaging techniques.
Patients with CMD may experience chest pain, reduced exercise tolerance, and other symptoms despite having minimal or no major coronary artery blockages.
Diagnosing microvascular disease remains one of cardiology’s significant clinical challenges because standard angiography frequently fails to identify abnormalities within the small coronary circulation.
By incorporating AI-based physiologic analysis, AngioInsight aims to expand diagnostic capabilities beyond large vessel disease to include assessment of coronary microvascular dysfunction.
This broader physiologic evaluation could improve diagnosis for patients whose symptoms remain unexplained despite apparently normal coronary angiograms.
Benchmarking Against Established Reference Standards
SMARTFLOW has been designed using established invasive physiologic reference standards as benchmarks for evaluating AngioAI+’s performance.
Using recognized clinical standards allows investigators to directly compare AI-generated assessments with accepted diagnostic methods currently used in cardiovascular practice.
This rigorous scientific approach is essential for determining whether AI-derived physiologic measurements provide sufficient accuracy to support future clinical adoption and regulatory review.
Benchmarking against established standards also enhances confidence in study findings by ensuring that software performance is evaluated using clinically validated reference measurements.
International Leadership Guides the Study
The SMARTFLOW study is co-led by two internationally respected experts in coronary physiology:
- Dr. Carlos Collet
- Dr. Todd C. Villines
Serving as Co-Principal Investigators, both physicians bring extensive experience in cardiovascular imaging, coronary physiology, interventional cardiology, and clinical research.
Their leadership reflects the study’s emphasis on scientific rigor, clinical relevance, and international collaboration.
By engaging recognized experts in coronary physiology, AngioInsight aims to ensure that SMARTFLOW generates evidence capable of informing both future research and clinical practice.
Dr. Carlos Collet Highlights the Study’s Potential
Commenting on the study launch, Dr. Carlos Collet described the first patient enrollment as the beginning of a new chapter in angiographic assessment of coronary artery disease.
According to Dr. Collet, the investigational software has been designed to process coronary angiograms automatically without requiring manual user interaction.
This fully automated workflow enables comprehensive evaluation of coronary lesions while simultaneously helping physicians identify coronary microvascular disease.
He emphasized that artificial intelligence has the potential to support physicians by accelerating diagnosis while improving both efficiency and clinical accuracy.
Automation may also reduce variability associated with manual interpretation, providing more consistent physiologic assessments across different healthcare settings.
Minneapolis Heart Institute Foundation Enrolls the First Patient
The first participant in SMARTFLOW was enrolled by Dr. Yader Sandoval and his research team at the Minneapolis Heart Institute Foundation (MHIF) located within Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital.
The Minneapolis Heart Institute Foundation serves as one of the United States’ leading cardiovascular research organizations and became the first clinical site activated for participation in the SMARTFLOW study.
Its selection reflects the institution’s long-standing reputation for conducting high-quality cardiovascular clinical research and advancing innovative approaches to patient care.
The successful enrollment of the first participant officially initiates patient recruitment across the broader multicenter investigation.
Expanding Physiologic Assessment
Dr. Sandoval emphasized the clinical importance of extending physiologic assessment beyond traditional evaluation of epicardial coronary artery disease.
Recent advances have demonstrated the value of angiography-derived physiology in assessing blockages affecting the major coronary arteries.
However, coronary microvascular disease continues to represent an important unmet diagnostic challenge.
According to Dr. Sandoval, SMARTFLOW seeks to address this need by enabling simultaneous assessment of both epicardial coronary disease and microvascular dysfunction from routine coronary angiography.
If validated, this capability could simplify physiologic testing while expanding access to comprehensive coronary functional assessment.
Such improvements may ultimately benefit patients who currently undergo limited physiologic evaluation because of procedural complexity or resource limitations.
AI Designed for Routine Clinical Practice
One of AngioAI+’s distinguishing features is its emphasis on automation.
The software has been developed to analyze coronary angiograms without requiring significant manual interaction from physicians or imaging specialists.
Automated image interpretation may improve workflow efficiency by reducing analysis time while minimizing operator-dependent variability.
Rather than replacing physician expertise, AngioAI+™ is intended to serve as a clinical decision-support tool that provides additional physiologic information to complement physician judgment.
This collaborative model aligns with broader trends in medical artificial intelligence, where AI systems assist clinicians rather than independently making treatment decisions.
Building Evidence for Future Regulatory Review
For AngioInsight, SMARTFLOW represents a foundational step toward future regulatory submissions.
Clinical evidence generated through prospective multicenter studies forms the basis for demonstrating both safety and effectiveness of new medical technologies.
According to Chief Executive Officer Scott Burger, the first patient enrollment reflects years of collaborative work involving physicians, engineers, scientists, clinical investigators, and technology developers.
He described SMARTFLOW as an important milestone that will help establish the clinical evidence necessary to support future regulatory filings for AngioAI+™.
The study also demonstrates AngioInsight’s commitment to validating its technology through rigorous scientific investigation before seeking broader commercialization.
Partnership with Minneapolis Heart Institute Foundation
Burger also highlighted the importance of launching SMARTFLOW at Minneapolis Heart Institute Foundation.
Having personally witnessed the quality of cardiovascular care delivered at Allina Health Minneapolis Heart Institute and Abbott Northwestern Hospital, he expressed appreciation for partnering with physicians and researchers known for both clinical excellence and scientific leadership.
He praised Dr. Sandoval and the research team for their dedication to innovation and patient-centered cardiovascular care, noting that their participation strengthens the overall scientific quality of the study.
The collaboration reflects AngioInsight’s strategy of partnering with highly respected cardiovascular centers capable of conducting rigorous clinical investigations.
Expanding Cardiovascular Research Through Artificial Intelligence
Beyond evaluating software performance, SMARTFLOW also seeks to advance broader scientific understanding of coronary physiology.
Burger emphasized that innovative science supported by rigorous clinical evidence remains central to AngioInsight’s mission.
The study aims to explore how artificial intelligence may uncover previously inaccessible physiologic insights from routine coronary angiography.
These insights could contribute to more comprehensive understanding of coronary function while supporting increasingly personalized cardiovascular care.
Supporting Diverse Patient Populations
An additional objective of SMARTFLOW is evaluating AI performance across diverse patient populations.
Historically, certain cardiovascular research populations—including women and other underrepresented groups—have been less extensively represented in clinical investigations.
AngioInsight believes broader inclusion is essential for developing AI technologies that perform reliably across varied patient demographics.
By enrolling patients from multiple clinical centers, SMARTFLOW seeks to strengthen understanding of coronary physiology across a wider range of populations while supporting more equitable cardiovascular care.
The enrollment of the first patient in the SMARTFLOW™ clinical study marks an important milestone in AngioInsight’s mission to transform cardiovascular diagnostics through artificial intelligence. As patient recruitment expands across participating clinical sites, the study will generate valuable evidence regarding the ability of AngioAI+™ to provide automated angiography-derived fractional flow reserve measurements and detect coronary microvascular disease using routine coronary angiographic images.
If successful, SMARTFLOW could demonstrate how AI-powered physiologic assessment enhances traditional coronary angiography by delivering faster, more comprehensive, and less invasive diagnostic insights. Supported by internationally recognized clinical investigators, leading cardiovascular research institutions, and rigorous scientific methodology, the study positions AngioInsight to advance the next generation of AI-enabled coronary physiology assessment while laying the foundation for future regulatory submissions and broader clinical adoption.
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