Cleerly LABS
Cleerly, Inc.Cleerly LABS is a cloud-based software used by trained medical professionals to process, analyze, and visualize coronary CT angiography images. It aids in detecting and assessing coronary artery disease by providing interactive tools for visualization and measurement of coronary arteries and plaque characteristics. The platform is intended to speed up clinical workflow and increase accuracy, while requiring review by qualified clinicians.
Intended Use
Cleerly LABS is a web-based software application intended to be used by trained medical professionals as an interactive tool for processing, analyzing and viewing cardiac computed tomography (CT) data to assess coronary anatomy in patients who have undergone Coronary Computed Tomography Angiography (CCTA) for the evaluation of coronary artery disease (CAD) or suspected CAD.
Technology
Cleerly LABS is a cloud-based, modular software-only device that processes coronary CT angiography scans, providing tools for visualization, segmentation, and measurement of coronary vessels and plaques via rule-based algorithms and interactive structured reporting. It acts as a core platform that can integrate results from add-on AI modules but performs only rule-based, non-ML analysis itself.
Performance
Comprehensive verification and validation were performed throughout the software lifecycle, including automated/manual testing, end-to-end workflow, and cybersecurity tests. Accuracy of coronary and plaque quantification was evaluated using 120 de-identified patient studies with expert-annotated references. Metrics such as vessel and lumen volume correlations were high, all exceeding acceptance thresholds, with overlap ratio of 94.8% and lumen/vessel volume correlations of 0.98.
Predicate Devices
No predicate devices specified
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