US-based AngioInsight is set to launch its pivotal SMARTFLOW clinical study to assess its AI-powered, software-only AngioAI+ platform’s diagnostic accuracy in cardiovascular diagnosis.
The platform aims to transform the way angiography imaging is interpreted using AI/machine learning (ML) algorithms, improving precision in diagnosing cardiovascular conditions, including coronary microvascular disease (CMD).
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Scheduled to begin this year, the study will involve subjects who are suspected of coronary artery disease (CAD) undergoing coronary angiography.
The study’s main objective is to assess the platform’s performance in estimating fractional flow reserve (FFR) and detecting CMD.
Dr Todd Villines at the University of Virginia, US; and Dr Carlos Collet at OLV Hospital, Belgium, will spearhead the study, which will be carried out across 15 US and European centres.
Following the study’s completion, the company intends to seek regulatory approval and marketing authorisation.
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By GlobalDataAngioInsight CEO Scott Burger said: “This study aims to validate the robustness of our AI-powered platform using data from real-world clinical settings.
“By harnessing AI’s power, the AngioAI+ platform will equip cardiologists with rapid and enhanced cardiovascular diagnostic capabilities, as well as identifying patients with CMD, with the goal of improving patient care outcomes.”
According to the company, the platform is tailored to deliver real-time three-dimensional reconstruction, “non-invasive” FFR estimations, as well as stenosis measurements.
Its AI algorithms are trained on extensive datasets to identify intricate patterns in angiography images, offering insights to support clinical decision-making.
Additionally, the platform is particularly focused on detecting CMD, a condition that is hard to diagnose, particularly in women.
The platform’s integration into current healthcare workflows could provide cardiologists with tools to accelerate angiographic evaluations and help the CAD functional assessment and diagnosis.
