CaRi-Plaque
Caristo Diagnostics Ltd.CaRi-Plaque is a web-based software application that aids trained medical professionals by automatically analyzing cardiac CT scans to quantify and characterize coronary artery plaques and stenoses. It provides detailed measurements on plaque volumes and vessel stenosis to help clinicians assess coronary artery disease and guide treatment decisions, complementing their clinical judgment.
Intended Use
Provide an optimized non-invasive application to analyze coronary anatomy and pathology from Computed Tomography (CT) Angiographic images to aid in determining treatment paths.
Technology
Web-based software analyzing CCTA DICOM data via 3D image thresholding algorithms combined with manual editing tools to quantify coronary plaques and stenoses, operated by trained professionals remotely using transmitted DICOM data.
Performance
Clinical validation with 117 subjects across four sites showed high agreement (Pearson correlation 0.817 to 0.999) between CaRi-Plaque measurements and expert readers for maximum stenosis, plaque volumes, and remodeling index, meeting acceptance criteria. Good inter- and intra-operator repeatability was also demonstrated.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/30/2024
6 months - 2
FDA Approval
2/20/2025
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