FDA clears Elucid’s FFR-IQ coronary imaging software

FFR-IQ calculates CT-derived fractional flow reserve values from coronary CT angiography images using AI-enabled algorithms.[2] The FDA indication is for clinically stable patients with suspected coronary artery disease, using previously acquired CT DICOM data that are analyzed quantitatively and qualitatively.[2] The FDA says results are intended to support qualified clinicians’ evaluation and assessment of coronary arteries.[2] It also says clinicians should consider results alongside clinical history, symptoms, other diagnostic tests and their own judgment.[2] The clearance letter is dated September 29, 2026.[2]

The FDA determined that FFR-IQ was substantially equivalent to legally marketed predicate devices.[2] Its 510(k) summary identifies Heartflow FFRct as the predicate.[2] The FDA classified FFR-IQ as a Class II coronary vascular physiologic simulation software device under regulation number 870.1415.[2] The summary describes the product as software as a service for use in healthcare facilities, hospitals or physician offices.[2] Elucid’s October 21, 2026 announcement said the product was commercially available.[1]

Elucid says its BioIntegrated FFR-CT approach incorporates coronary anatomy and plaque characteristics into the physiological estimate.[1] The company says its platform integrates coronary anatomy, physiology and plaque biology from a single CCTA, and that Plaque-IQ evaluates stenosis, plaque burden and composition, including lipid-rich necrotic core.[1] Elucid reported overall sensitivity of 92.2% and specificity of 93.1% in the ELUCIDATE FFR-CT study.[1] The company described these as the highest results of any FFR-CT validation study.[1]

Elucid says FFR-CT may help avoid the majority of unnecessary catheterizations while identifying flow-limiting disease that requires revascularization.[1] CEO Kelly Huang said physicians had told the company they wanted a more accurate FFR-CT.[1]