Cleerly LABS
Overview
Cleerly LABS is a web-based software application that leverages artificial intelligence (AI) to provide advanced cardiovascular imaging analysis. It is designed for use by trained medical professionals to view and analyze cardiac computed tomography (CT) data, specifically Coronary Computed Tomography Angiography (CCTA) images. The platform enables comprehensive phenotyping of coronary artery disease (CAD) by determining the presence, extent, and type of coronary plaques (atherosclerosis) and stenosis. Cleerly LABS, often used in conjunction with the Cleerly ISCHEMIA module, offers detailed insights into plaque composition (e.g., soft, mixed, calcified), arterial narrowing, and the likelihood of ischemia in specific vessels. This AI-driven approach aims to support physicians in earlier diagnosis, personalized treatment planning, and tracking disease progression, ultimately working towards the prevention of heart attacks.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-powered CCTA image analysis
- Comprehensive coronary plaque assessment (volume, type)
- Stenosis detection and quantification
- Ischemia detection (with Cleerly ISCHEMIA module)
- 3D visualization of coronary arteries
- Personalized heart disease risk assessment
- Tracking disease progression over time
- Integration with PACS, RIS, EHR via Cleerly Proxy
- Automated data upload and report delivery
- Validated against invasive imaging modalities and expert readers
Use Cases
- Early detection of atherosclerosis and CAD
- Personalized treatment planning for heart disease
- Risk stratification for major adverse cardiovascular events (MACE)
- Monitoring efficacy of lifestyle and medical therapies
- Diagnostic aid for patients undergoing CCTA
- Patient education and engagement in heart health
What Physicians Need to Know
Cleerly LABS offers a powerful AI-driven platform for detailed coronary artery assessment using CCTA, enabling personalized risk assessment and treatment planning for coronary artery disease (CAD). Physicians can leverage its ability to identify and characterize high-risk plaque, quantify stenosis, and detect ischemia to guide interventions, potentially reducing unnecessary invasive procedures. The platform supports tracking disease progression over time with serial scans, allowing for tailored therapeutic adjustments. It's crucial to integrate Cleerly's comprehensive reports with other clinical data for a holistic patient diagnosis and management strategy.
Cleerly LABS is designed for seamless integration into existing imaging center workflows. It supports various CCTA upload methods (direct, Nuance Powershare, Intelerad Inteleshare, Cleerly Proxy) and integrates with radiology reporting systems like Nuance PowerScribe via API for efficient data transfer and structured reporting. This allows for streamlined workflows and reduced manual data entry within existing hospital and practice environments.
Details
| Category | Cardiology AI, Radiology & Imaging AI |
| Pricing |
Per analysis
|
| Deployment | Cloud-based (AWS), web-based application, with on-site Cleerly Proxy for data transfer. |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated Cleerly LABS (K242338) is FDA-cleared as a web-based software for viewing and analyzing cardiac CT data to determine the presence and extent of coronary plaques and stenosis. Cleerly ISCHEMIA (K231335), an add-on module, is also FDA-cleared as an automated machine learning-based decision support tool for detecting likely ischemia. |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology, Radiology |
What the Web Says
Cleerly LABS offers AI-powered analysis of CT angiograms to identify and quantify plaque in coronary arteries, aiming to provide a more precise assessment of heart disease risk beyond traditional methods. Reviews highlight its potential to improve diagnostic accuracy and personalize treatment plans, though some note the novelty of the technology and integration challenges.
Overall: PositiveStrengths
- Improved diagnostic accuracy for coronary artery disease (CAD)
- Quantification of plaque, not just stenosis, for better risk assessment
- Potential to personalize treatment and prevention strategies
- Non-invasive imaging analysis
- Aids in identifying 'silent' heart disease before symptoms appear
- Supported by clinical studies demonstrating efficacy
Limitations
- New technology, requiring education for widespread adoption
- Integration into existing clinical workflows can be a challenge
- Cost of the service may be a barrier for some institutions/patients
- Requires specialized CT angiography, not universally available
- Interpretation still requires physician oversight and expertise
- Potential for over-diagnosis or anxiety in some patients due to detailed findings
Based on reviews from: Physician reviews (various medical forums and articles), Healthcare IT publications, Tech review sites (focused on medical technology), Reddit (discussions in medical/health subreddits), G2 (no specific reviews found for 'Cleerly LABS', general Cleerly mentions), Capterra (no specific reviews found for 'Cleerly LABS')
Last updated: 2026-07-17
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