Cleerly ISCHEMIA
Cleerly, Inc.Cleerly ISCHEMIA is an automated software tool that uses AI to analyze CT angiography scans of the heart. It helps doctors determine if patients have signs of ischemia (inadequate blood flow) caused by coronary artery disease, supporting more informed patient care decisions.
Intended Use
Cleerly ISCHEMIA analysis software is an automated machine learning-based decision support tool, indicated as a diagnostic aid for patients undergoing CT analysis using Cleerly LABS software. When utilized by an interpreting healthcare provider, this software tool provides information that may be useful in detecting likely ischemia associated with coronary artery disease.
Technology
Cleerly ISCHEMIA is an add-on software module to Cleerly LABS that uses quantitative CT-based measures (atherosclerosis, stenosis, and vascular morphology) to assess the likely presence or absence of coronary vessel ischemia. It outputs a Cleerly ISCHEMIA Index (CII) to aid interpretation, utilizing machine learning algorithms.
Performance
Performance testing included software verification/validation and clinical validation on a representative multi-site cohort, confirming that the device continues to perform as intended, with no clinically significant differences from the predicate. Software testing included risk management, simulated and real data testing, and regression analysis.
Predicate Devices
No predicate devices specified
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