Cleerly
Overview
Cleerly is an FDA-cleared, cloud-based digital health platform that utilizes machine learning and advanced image analysis to evaluate coronary computed tomography angiography (CCTA) scans. Moving beyond traditional luminal stenosis grading and coronary artery calcium (CAC) scoring, Cleerly identifies, characterizes, and quantifies atherosclerosis at the individual vessel and whole-heart level.
The platform delivers precise measurements of total plaque volume, plaque composition (such as low-attenuation, fibrofatty, fibrous, and calcified plaque), and vascular morphology. Through its advanced analytics suite—including Cleerly Plaque Analysis, Cleerly ISCHEMIA, and Cleerly COMPARE—clinicians can identify high-risk non-calcified plaque, evaluate vessel-specific ischemia non-invasively, and track disease progression or regression over serial imaging studies.
Validated in major prospective clinical trials such as CREDENCE and PACIFIC, Cleerly equips cardiologists, radiologists, and primary care physicians with actionable, standardized reporting. By identifying patient-specific plaque phenotypes before adverse cardiac events occur, clinicians can optimize preventative pharmacotherapy and reduce unnecessary invasive coronary angiographies.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Automated whole-heart coronary artery segmentation and lumen centerline extraction
- Quantification of total atheroma volume and percent atheroma volume (PAV)
- Plaque characterization into low-attenuation plaque (LAP), fibrofatty, fibrous, and calcified tissue
- Cleerly ISCHEMIA non-invasive vessel-specific ischemia prediction
- Cleerly COMPARE serial scan tracking to monitor plaque progression or regression under therapy
- 2D and 3D stenosis severity measurement across all major epicardial coronary vessels
- CAD-RADS 2.0 aligned reporting with high-risk plaque feature flags
- Direct PACS, cloud DICOM routing, and EHR-compatible report export
Use Cases
- Evaluating symptomatic stable chest pain patients presenting for outpatient CCTA
- Identifying high-risk non-calcified plaque vulnerable to rupture in early-stage CAD
- Non-invasive physiological assessment of coronary stenosis to reduce diagnostic invasive angiograms
- Monitoring patient response and plaque regression during intensive lipid-lowering medical therapy
- Cardiovascular risk stratification in asymptomatic patients with elevated risk factors
Details
| Category | Cardiology AI, Clinical Decision Support & Reference, Radiology & Imaging AI |
| Pricing |
Enterprise
|
| Free Trial | No |
| Deployment | Cloud |
| Mobile App | None |
| API Available | Yes |
| Data Export | Yes |
| Languages | English |
| Training | Yes |
| Target Size | Cardiology clinics, outpatient imaging centers, and hospital networks |
| Compliance | |
| BAA Available | Yes AI-estimated |
| HIPAA Compliant | Yes AI-estimated |
| FDA Status | Cleared AI-estimated — K193638 (Cleerly LAB / Plaque Analysis); K213271 (Cleerly ISCHEMIA) |
| SOC 2 | Yes AI-estimated |
| Integrations | |
| EHR | Cerner, Epic |
| Specialties | Cardiology, Internal Medicine, Preventive Medicine, Radiology |
Social Proof
| Customers | unknown |
| Notable | Cleerly is deployed across leading academic medical centershealth systemsand imaging networks across the United States. |
Support & Reliability
| Training Provided | Yes |
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