BOSTON — Elucid, a developer of artificial intelligence-powered cardiovascular imaging technology, announced that the U.S. Food and Drug Administration has granted 510(k) clearance for FFR-IQ, its software designed to noninvasively assess blood flow restrictions in coronary arteries and help physicians make more informed treatment decisions.
The company also announced the commercial availability of the software, which uses coronary CT angiography (CCTA) images to estimate fractional flow reserve (FFR), a measurement used to determine whether narrowing in a coronary artery is restricting blood flow to the heart muscle.
Elucid said its technology combines coronary anatomy with plaque composition to provide a more comprehensive assessment of cardiovascular disease without requiring invasive procedures.
Traditionally, FFR has been measured using a pressure wire inserted during cardiac catheterization to determine whether patients may benefit from procedures such as coronary stenting or bypass surgery.
By estimating FFR through CT imaging, Elucid’s software is designed to help physicians identify patients who may require invasive evaluation or treatment while potentially reducing unnecessary catheterizations.
The FDA clearance was supported by the ELUCIDATE FFR-CT study, which demonstrated an overall sensitivity of 92.2% and specificity of 93.1%. According to Elucid, these results represent the highest diagnostic accuracy reported in an FFR-CT validation study.
The company is integrating FFR-IQ with its existing FDA-cleared Plaque-IQ platform to provide physicians with information about coronary anatomy, blood flow and plaque characteristics from a single CT scan.
Plaque-IQ evaluates arterial narrowing, plaque burden and composition, including lipid-rich necrotic core, a component associated with certain high-risk atherosclerotic plaques.
Elucid said the combined platform incorporates plaque characteristics into estimates of coronary blood flow, potentially allowing physicians to better assess individual lesions and personalize treatment decisions.
“Plaque composition, coronary anatomy, and physiology are closely connected,” said Amir Ahmadi, MD, FACC, FSCCT, clinical associate professor of medicine (cardiology) at the Icahn School of Medicine at Mount Sinai and Elucid’s lead scientific advisor.
“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.”
Kelly Huang, PhD, CEO of Elucid, said the clearance represents an important advancement in the company’s efforts to improve cardiovascular diagnostics.
“Physicians have told us they want a more accurate FFR-CT, and we’re thrilled to deliver on that need with the most accurate,” Huang said. “Elucid’s mission is predicting and personalizing the prevention of heart attacks and strokes, and our high-performing FFR-IQ, alongside Plaque-IQ, is intended to be a step change for current patient care and a step forward to the future of personalized medicine in cardiology.”
Elucid plans to present detailed results from the ELUCIDATE FFR-CT study at the annual Transcatheter Cardiovascular Therapeutics conference in San Diego on November 1.
The company will also conduct hands-on training sessions and demonstrate its FFR-IQ and Plaque-IQ technologies during the conference.
The FDA clearance allows Elucid to market FFR-IQ in the United States for its cleared intended use, expanding the company’s portfolio of AI-based cardiovascular imaging solutions.
