Boston-based cardiovascular imaging AI developer Elucid has received U.S. Food and Drug Administration (FDA) 510(k) clearance for FFR-IQ, its software for estimating fractional flow reserve (FFR) from coronary CT angiography.
FFR-IQ builds coronary anatomy and plaque composition into its physiological estimate, drawing on measurements from the firm’s Plaque-IQ software, including lipid-rich necrotic core. Elucid is combining FFR-IQ and Plaque-IQ in a single platform that assesses anatomy, physiology, and plaque from a single coronary CT angiography scan, with a new interface and reporting workflow, it said.
In the ELUCIDATE FFR-CT validation study supporting the clearance, the software showed 92.2% sensitivity and 93.1% specificity against invasive FFR, according to the company.
