CaRi-Plaque
Overview
CaRi-Plaque is an FDA-cleared, AI-assisted image analysis application developed by Caristo Diagnostics. It is designed for the non-invasive analysis of coronary anatomy and pathology from routine coronary CT angiography (CCTA) scans. The tool helps healthcare professionals determine the presence, extent, and severity of coronary plaques and quantifies luminal stenosis (narrowing of arteries).
The CaRi-Plaque report provides comprehensive and actionable data, including visual representations of each coronary vessel and associated quantitative outputs such as Maximum Stenosis, Total Plaque Volume, Calcified Plaque (CP) Volume, Non-calcified Plaque (NCP) Volume, Low Density Non-calcified Plaque (LD-NCP) Volume, Plaque Burden, and Remodelling Index.
The workflow is secure and seamless: CT scan data is sent to the cloud, de-identified by Caristo, processed through the CaRi-Plaque software for preliminary plaque analysis, and then reviewed by trained internal operators. The final CaRi-Plaque Report is delivered to the originating healthcare professional in either DICOM-conformant or PDF format.
CaRi-Plaque builds on Caristo’s broader CaRi-Heart technology, which also quantifies coronary inflammation and generates an individualized risk score for coronary artery disease.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-assisted plaque analysis
- Measures maximum stenosis
- Quantifies total plaque volume
- Quantifies calcified plaque (CP) volume
- Quantifies non-calcified plaque (NCP) volume
- Quantifies low-density non-calcified plaque (LD-NCP) volume
- Determines plaque burden
- Calculates remodeling index
- Provides visual representations of coronary vessels
- Generates DICOM-conformant or PDF reports
Use Cases
- Non-invasive analysis of coronary anatomy and pathology from routine CCTA scans
- Diagnosis of coronary artery disease (CAD)
- Early detection of coronary plaques
- Personalized heart attack prevention
- Aiding clinicians in understanding a patient's cardiovascular risk profile
- Supporting drug clinical trials and clinical research
What Physicians Need to Know
Physicians can leverage CaRi-Plaque for early and precise assessment of coronary artery disease by quantifying plaque characteristics and stenosis from routine CCTA scans. When utilized as part of the CaRi-Heartu00ae platform, it provides a comprehensive view of cardiac risk by also assessing coronary inflammation (FAI-Scoreu2122) and generating an individualized risk score. This enables proactive, personalized prevention and treatment strategies, even in asymptomatic patients or those with non-obstructive disease, potentially leading to earlier intervention and improved patient outcomes. CaRi-Plaque is FDA cleared and has established reimbursement pathways, streamlining its integration into clinical workflows.
CaRi-Plaque operates as a cloud-based Software as a Service (SaaS) medical device. It offers a seamless workflow where CT scan data can be securely sent to the cloud, de-identified, and processed. The generated CaRi-Plaque reports are delivered to healthcare professionals in DICOM-conformant or PDF format. The system is designed to analyze new or archived images from most scanner models or PACS systems, facilitating integration into existing imaging infrastructure.
Details
| Category | Cardiology AI, Radiology & Imaging AI |
| Pricing |
Contact for pricing
|
| Deployment | Cloud-based |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated CaRi-Plaque received U.S. Food and Drug Administration (FDA) 510(k) clearance (K242240) on February 20, 2025. It is an AI-assisted image analysis application intended to aid the diagnosis of coronary artery disease (CAD) and is regulated as a Class II Medical Image Management and Processing System (21 CFR 892.2050, Product Code LLZ). |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology, Radiology |
What the Web Says
CaRi-Plaque, developed by Caristo Diagnostics, is an AI-powered medical device designed to analyze CT angiograms to detect and characterize vulnerable plaque in coronary arteries, aiming to predict heart attacks. Reviews highlight its potential to revolutionize cardiovascular risk assessment by providing more granular and predictive information than traditional methods.
Overall: PositiveStrengths
- Early detection of vulnerable plaque, potentially preventing heart attacks.
- Non-invasive analysis using existing CT angiography scans.
- AI-driven precision for improved diagnostic accuracy.
- Potential to personalize patient risk stratification and treatment.
- FDA cleared, indicating regulatory approval and safety.
- Integration with existing imaging workflows.
Limitations
- Relatively new technology, long-term clinical outcomes still being established.
- Requires specialized interpretation and understanding by clinicians.
- Potential for over-diagnosis or unnecessary interventions if not used judiciously.
- Cost implications for healthcare systems and patients (though not widely discussed yet).
- Limited widespread adoption and familiarity among all physicians.
- Data privacy and security concerns inherent with AI in healthcare (general concern, not specific to CaRi-Plaque).
Based on reviews from: Caristo Diagnostics official website, FDA clearance announcements, Medical technology news outlets, Cardiology journals and research papers, Healthcare IT publications, Physician forums (general discussions on AI in cardiology)
Last updated: 2026-07-20
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How does CaRi-Heart analysis work?
