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Cleerly LABS is a web-based software application that is intended to be used by trained medical professionals as an interactive tool for viewing and analyzing cardiac computed tomography (CT) data for determining the presence and extent of coronary plaques (i.e. atherosclerosis) and stenosis in patients who underwent Coronary Computed Tomography (CCTA) for evaluation of CAD or suspected CAD. This software post processes CT images obtained using any Computed Tomography (CT) scanner. The software provides tools for the measurement and visualization of coronary arteries. The software is not intended to replace the skill and judgment of a qualified medical practitioner and should only be used by people who have been appropriately trained in the software's functions, capabilities and limitations. Users should be aware that certain views make use of interpolated data. This is data that is created by the software based on the original data set. Interpolated data may give the appearance of healthy tissue in situations where pathology that is near or smaller than the scanning resolution may be present.

Cleerly LABS is a post-processing web-based software application that enables trained medical professionals to analyze 2D/3D coronary images acquired from Coronary Computed Tomography Angiography (CCTA) scans. The software is a post-processing tool that aids in determining treatment paths for patients suspected of having coronary artery disease (CAD). Cleerly LABS utilizes machine learning and simple rule-based mathematical calculation components which are performed on the backend of the software. The software applies deep learning methodology to identify high quality images, segment and label coronary arteries, and segment lumen and vessel walls. 2D and 3D images are presented to the user for review and manual editing. This segmentation is designed to improve efficiency for the user, and help shorten tedious, timeconsuming manual tasks. The user is then able to edit the suggested segmentation as well as adjust plaque thresholds, demarcate stenosis, stents, and chronic total occlusions (CTOs) as well as select dominance and indicate coronary anomalies. Plaque, stenosis, and vessel measurements are output based on the combination of user-editable segmentation and user-placed stenosis, stent, and CTO markers. These outputs are mathematical calculations and are not machine-learning based. Cleerly LABS provides a visualization of the Cleerly LABS analysis in the CORONARY Report. The CORONARY Report uses data previously acquired from the Cleerly LABS image analysis to generate a visually interactive and comprehensive report that details the atherosclerosis and stenosis findings of the patient. This report is not intended to be the final report (i.e., physician report) used in patient diagnosis and treatment. Cleerly Labs provides the ability to send the text report page of the CORONARY Report to the user's PACS system. Cleerly LABS software does not perform any functions that could not be accomplished by a trained user with manual tracing methods or other commercially available software. Rather, it represents a more robust semiautomatic software intended to enhance the performance of time-intensive, potentially error-prone, manual tasks, thereby improving efficiency for medical professionals in the assessment of coronary artery disease (CAD).

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. Patient management decisions should not be made solely on the results of the Cleerly ISCHEMIA analysis.

Cleerly ISCHEMIA is an add-on software module to Cleerly Labs (K202280, K190868) that determines the likely presence or absence of coronal vessel ischemia based on quantitative measures of atherosclerosis, stenosis, and significant vascular morphology from typically-acquired Coronary Computed Tomography Angiography images (CCTA). Cleerly ISCHEMIA, in conjunction with Cleerly Labs, outputs a Cleerly ISCHEMIA Index (CII), a binary indication of negative CII (likely absence of ischemia) or positive CII (likely presence of ischemia) with its threshold equivalent to invasive FFR >0.80 vs. ≤0.80, respectively, as identified in professional societal practice guidelines.

Cleerly Labs is a web-based software application that is intended to be used by trained medical professionals as an interactive tool for viewing and analyzing cardiac computed tomography (CT) data for determining the presence and extent of coronary plaques (i.e. atherosclerosis in patients who underwent Coronary Computed Tomography Angiography (CCTA) for evaluation of CAD or suspected CAD. This software post processes CT images obtained using any Computed Tomography (CT) scanner. The software provides tools for the measurement and visualization of coronary arteries. The software is not intended to replace the skill and judgment of a qualified medical practitioner and should only be used by people who have been appropriately trained in the software's functions, capabilities and limitations. Users should be aware that certain views make use of interpolated data. This is created by the software based on the original data set. Interpolated data may give the appearance of healthy tissue in situations where pathology that is near or smaller than the scanning resolution may be present.

Cleerly Labs is a post-processing web-based software application that enables trained medical professionals to analyze 2D/3D coronary images acquired from Coronary Computed Tomography (CCTA) scans. The software is a post-processing tool that aids in determining treatment paths for patients suspected to have coronary artery disease (CAD). Cleerly Labs utilizes machine learning and simple rule-based mathematical calculation components which are performed on the backend of the software applies deep learning methodology to identify high quality images, segment and label coronary arteries, and segment lumen and vessel walls. 2D and 3D images are presented to the user for review and manual editing. This segmentation is designed to improve efficiency for the user, and help shorten tedious, time-consuming manual tasks. The user is then able to edit the suggested segmentation as well as adjust plaque thresholds, and demarcate stenosis, stents, and chronic total occlusions (CTOs) as well as select dominance and indicate coronary anomalies. Plaque, stenosis, and vessel measurements are output based the combination of user-editable segmentation and user-placed stent, and CTO markers. These outputs are mathematical calculations and are not machine-learning based. Cleerly Labs provides a visualization of the Cleerly Labs analysis in the CORONARY Report. The CORONARY Report uses data previously acquired from the Cleerly Labs image analysis to generate a visually interactive and comprehensive report that details the atherosclerosis and stenosis findings of the patient. This report is not intended to be the final report (i.e., physician report) used in patient diagnosis and treatment. Cleerly Labs provides the ability to send the text report page of the CORONARY Report to the user's PACS system. Cleerly Labs software does not perform any functions that could not be accomplished by a trained user with manual tracing method or other commercially available software. Rather, it represents a more robust semiautomatic software intended to enhance the performance of time-intensive, potentially error-prone, manual tasks, thereby improving efficiency for medical professionals in the assessment of coronary artery disease (CAD).