FDA Clears AI-Based FFR-IQ to Compute Fractional Flow Reserve from Coronary CTA

FDA 510(k) clears Elucid's FFR-IQ AI software for noninvasive estimation of fractional flow reserve (FFR) from coronary CT angiography. In a recent study, it demonstrated 92.2% sensitivity and 93.1% specificity for FFR-CT.

• The software uses BioIntegrated FFR-CT technology, incorporating plaque composition and coronary anatomy into the physiological estimate.
• Designed to help physicians assess individual lesion significance and the patient's broader atherosclerotic disease burden, guiding preventive treatment.

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