Cleerly Labs
Cleerly IncCleerly Labs is a web-based software application that helps trained medical professionals view and analyze cardiac CT images, specifically from Coronary Computed Tomography Angiography (CCTA). It assists in identifying and measuring coronary artery plaques and stenosis to help evaluate coronary artery disease or suspected CAD, providing detailed visualizations and measurements to support clinical decision-making.
Intended Use
Cleerly Labs is a web-based software application 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 and stenosis in patients who underwent Coronary Computed Tomography Angiography (CCTA) for evaluation of CAD or suspected CAD. The software post processes CT images obtained using any CT scanner and provides tools for measurement and visualization of coronary arteries.
Technology
Cleerly Labs is a post-processing web-based software application used by trained professionals to analyze 2D/3D coronary images from CT angiographic scans. It supports manual and semi-automatic segmentation of coronary artery images, providing visualization and measurement tools for lumen wall, vessel wall, plaque, stenosis, and remodeling index. Users can edit segmentations and demarcate stenosis and stents, with outputs based on user edits and measurements. It runs as a client-server Google Chrome application compatible with DICOM CT images.
Performance
The software underwent extensive software verification and validation, usability testing with board-certified radiologists and technicians, and cybersecurity penetration testing. Its machine learning algorithms were evaluated against multiple expert ground truth readers, demonstrating high correlation coefficients and agreement in measurements such as lumen volume, vessel volume, and plaque volume. No clinical testing was required as non-clinical bench testing was sufficient.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/3/2019
7 months - 2
FDA Approval
11/5/2019
Other devices from Cleerly Inc
- Cleerly ISCHEMIA2023 • 510K
- Cleerly Labs v2.02020 • 510K
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