FDA Clears AI-Enabled FFR-IQ Software for Estimating Fractional Flow Reserve from CCTA

The Food and Drug Administration (FDA) has issued a 510(k) clearance for the AI-powered FFR-IQ software, which provides fractional flow reserve (FFR) estimates from coronary computed tomography angiography (CCTA) images.

Employing the proprietary technology BioIntegrated FFR-CT, the FFR-IQ software includes plaque composition and coronary anatomy into the coronary physiology estimates, according to Elucid, the developer of the FFR-IQ software. Through non-invasive assessment of FFR, the company said the FFR-IQ software may help reduce unnecessary catheterization procedures by identifying which patients are better suited for revascularization and which patients may benefit from invasive treatments.

Elucid pointed out that a recent study of the FFR-IQ software revealed overall sensitivity and specificity rates of 92.2 percent and 93.1 percent, respectively, in estimating FFR from CCTA scans.

“Plaque composition, coronary anatomy, and physiology are closely connected,” said Amir Ahmadi, MD, FACC, FSCCT, a clinical associate professor of medicine (cardiology) at the Icahn School of Medicine at Mount Sinai and lead scientific advisor for Elucid. “BioIntegrated FFR-CT incorporates anatomy and plaque characteristics into the physiological estimate itself. Together with plaque assessment, this approach can help physicians evaluate the significance of an individual lesion while also addressing the patient’s broader atherosclerotic disease and need for preventive treatment.”