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# FDA Clears PlaqueIQ for Cardiovascular Disease
- URL: https://www.fdaweb.com/fda-clears-plaqueiq-for-cardiovascular-disease/
- Published: 2024-10-04T12:00:00.000Z
- Updated: 2026-09-14T14:43:15.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157922

FDA has cleared an Elucid 510(k) for its PlaqueIQ imaging analysis software to help physicians diagnose cardiovascular disease. The software is designed to “objectively quantify and classify plaque morphology based on ground-truth histology, the gold standard for characterization of plaques,” the company says, adding that it is intended to give physicians clinically validated information to help “stratify patients and inform patient-specific treatment pathways.”

Elucid says PlaqueIQ uses first-line diagnostic coronary computed tomography angiography to develop comprehensive, interactive reports to help physicians virtually examine plaque at the vessel level. “With its basis in histology, the software is uniquely able to non-invasively quantify and characterize non-calcified plaque and its components such as lipid-rich necrotic core (LRNC), giving potential insights into high-risk plaques that are key drivers of risk of heart attack and stroke.”

To evaluate plaque buildup, physicians electronically send patient images to Elucid, it says, and PlaqueIQ’s image-restoration algorithms are applied to the file to mitigate motion and calcium blooming artifacts. “Specially trained analysts segment the data creating a 3D model of the patient’s coronary arteries,” it says, and the software then identifies, classifies and quantifies tissue structure and composition.