Cleerly

by Cleerly  · Based in United States → — Personalized Analysis and Treatment of Heart Disease
Cardiology Internal Medicine preventive-medicine

Varies
Documentation ProvidedRegulatory Status Disclosed

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

What Physicians Need to Know

Cardiac CT/MRI Analysis
Cleerly specializes in the AI-powered analysis of Coronary Computed Tomography Angiography (CCTA) scans. It transforms standard CCTA scans into detailed 3D maps of the heart's arteries. The AI algorithms identify, characterize, and quantify plaque (including soft, calcified, and mixed plaque), measure plaque volume, composition, length, and location, and evaluate stenosis severity in both 2D and 3D. This provides a comprehensive view of atherosclerosis and helps detect early signs of coronary artery disease (CAD) before symptoms appear.
Coronary Artery Assessment
Cleerly provides a thorough evaluation of the presence, amount, and type of plaque in the heart's arteries. It differentiates between high-risk and low-risk plaques, including soft, lipid-rich plaques that are prone to rupture and often missed by traditional calcium scoring. The platform also assesses the likelihood of ischemia in specific vessels, using an algorithm based on invasive FFR data to determine if ischemia is likely present or unlikely present. This detailed analysis helps in personalizing treatment plans and tracking disease progression over time.
Heart Failure Risk Prediction
By providing advanced plaque analysis and identifying high-risk plaque characteristics, Cleerly helps in assessing a patient's unique risk of heart attack. This allows healthcare providers to take proactive measures to prevent potential heart attacks and make informed, data-driven decisions about heart health.
AHA/ACC Guideline Alignment
Cleerly's analysis aligns with the American College of Cardiology (ACC) guidelines on the use of CCTA for non-invasive heart disease evaluation. The ACC/AHA guidelines highlight the importance of plaque, particularly high-risk plaque, as a driver of major adverse cardiovascular events (MACE).
Real-Time Alert Capability
Cleerly's average processing time for CCTA uploads is 1 hour and 20 minutes, with results received via email, DICOM PDF, DICOM SC, or a web portal.
Physician Tip

Cleerly provides quantitative measurements of plaque, stenosis, and likelihood of ischemia, offering a comprehensive view of coronary artery disease. This can help in personalizing therapy and monitoring plans, especially for patients with risk factors but no known CAD, those with borderline calcium scores, or for serial monitoring to track plaque changes over time. The detailed reports and interactive web platform can aid in patient education and engagement. Consider a baseline Cleerly scan in the early 50s for average-risk individuals, and sooner for those with a family history or concerning markers. Follow-up scans can be tailored based on disease severity.

Cleerly integrates with radiology reporting solutions like Nuance PowerScribe (360 and One) via API, sending analysis results directly into CCTA reports. CCTA uploads for Cleerly analysis can be done through direct upload, the Nuance Powershare network, Intelerad Inteleshare, and Cleerly Proxy, a cloud-based solution that integrates into existing hospital and practice workflows. Cleerly also partners with organizations like Cardiac Care Alliance to integrate its AI-powered coronary artery assessment technology into cardiovascular care networks. As of January 2026, AI plaque analysis has its own Medicare billing code (CPT 75577), and private insurers covering over 86 million Americans now cover it.

Details

Category Cardiology AI, Clinical Decision Support & Reference, Radiology & Imaging AI
Pricing Varies
DeploymentCloud, On-premise (virtual appliance)
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Cleared AI-estimated
SOC 2 Yes AI-estimated
Integrations
EHR Cerner, Epic
Specialties Cardiology, Internal Medicine, Preventive Medicine, Radiology

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Ease of Use
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Press & Coverage

BioSpace
Cleerly Announces New Findings on How AI-QCT Plaque Measurements Relate to Long-Term Cardiovascular Risk
Cleerly announced new study findings at the European Society of Cardiology (ESC) Congress 2026, published simultaneously in EJNMMI, demonstrating that AI-quantified plaque burden is independently associated with cardiovascular events over 3, 6, and 9 years in patients with suspected coronary artery disease.
2026-09
Cleerly
Cleerly and Allelica Partner to Launch a Polygenic Risk Score Test for Coronary Artery Disease
Cleerly and Allelica have partnered to introduce a polygenic risk score test for coronary artery disease.
2026-07
Business Wire
Aetna Approves Coverage for Cleerly's AI Cardiovascular Imaging Analysis
Aetna will now cover Cleerlyu00ae LABS plaque analysis, joining other major payors like UnitedHealthcare, Cigna, Humana, and Medicare in providing coverage for this AI-based cardiovascular imaging technology.
2026-01
Cleerly
Cleerly Secures CPTu00ae Category I Code for AI-QCT Advanced Plaque Analyses
The American Medical Association (AMA) has approved a CPTu00ae Category I code for Cleerly's AI-QCT advanced plaque analyses, effective January 2026, marking a significant step for AI-driven cardiovascular care.
2024-10
Cleerly
Cleerlyu00ae Receives FDA Breakthrough Device Designation for Heart Disease Risk Staging System
Cleerly has been granted Breakthrough Device Designation by the FDA for its Coronary Artery Disease (CAD) Staging System, an investigational software device that noninvasively analyzes features of coronary atherosclerosis, stenosis, and ischemia.
2024-03
Cleerly
Cleerlyu00ae ISCHEMIAu2122 Demonstrates Diagnostic Accuracy and Prognostic Utility
Cleerly shared findings from a study published in the Journal of the American College of Cardiology: Cardiovascular Imaging, validating its AI-guided quantitative coronary CT angiography (AI-QCT) ISCHEMIA technology for diagnostic accuracy and prognostic risk stratification.
2024-03
Diagnostic and Interventional Cardiology
Results of CERTAIN Study Demonstrate Prominent Effects of Cleerly Products on Changing Clinical Management for Patients Suspected of Coronary Artery Disease
The CERTAIN study showed that using Cleerly's comprehensive evaluation of coronary atherosclerosis, stenosis, and ischemia led to significant changes in clinical management, including a 39% change in stenosis assessment and a 37% reduction in the need for further testing.
2024-02
DocWire News
Cleerly Uses An AI-Based Digital Platform to Transform the Treatment of Heart Disease
Cleerly is transforming heart disease diagnosis with its AI-based digital platform, which uses imaging to enable earlier detection of atherosclerosis and personalized treatment plans.
2023-11

Videos

Product demos, reviews, and walkthroughs for Cleerly.

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Frequently Asked Questions

Cleerly's AI platform analyzes standard cardiac CT angiography (CCTA) scans to provide a comprehensive, AI-driven quantification and characterization of coronary plaque. This integrates by offering physicians detailed reports on plaque volume, type, and stenosis severity, aiding in risk stratification and treatment planning beyond traditional visual assessment.
Cleerly has received FDA 510(k) clearances for its various modules, indicating its compliance as a medical device. The company adheres to stringent data security protocols, including HIPAA compliance, to protect patient health information throughout the data processing and reporting workflow.
While other solutions may offer aspects of cardiac imaging analysis, Cleerly differentiates itself by providing a comprehensive, AI-driven phenotyping of coronary artery disease directly from CCTA. This includes detailed plaque characterization and quantification, which goes beyond simple stenosis detection offered by some alternatives, aiming for a more precise understanding of individual patient risk.
Cleerly's pricing model typically involves a per-study fee for its analysis and reporting services. Reimbursement for Cleerly's services is evolving, with increasing recognition and coverage from various insurance carriers as the clinical utility and cost-effectiveness of precise CAD phenotyping become more established.
While highly effective, Cleerly's AI, like any diagnostic tool, has limitations. These may include challenges in cases with extensive motion artifact, very high calcium scores that can obscure plaque, or certain complex post-surgical anatomies. Physicians should consider these factors when interpreting results and integrate them with their overall clinical judgment.
Cleerly's detailed plaque analysis and quantification provide objective, reproducible data that can significantly enhance clinical decision-making beyond traditional CCTA interpretation. This allows for more precise risk stratification, personalized treatment strategies, and potentially more targeted interventions for patients with coronary artery disease.
Cleerly's technology is supported by numerous peer-reviewed validation studies demonstrating its accuracy and efficacy in quantifying and characterizing coronary plaque. These studies often compare Cleerly's AI-driven analysis against intravascular ultrasound (IVUS) and other gold-standard methods for CAD assessment.

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More from Cleerly

Cleerly ISCHEMIA
Cleerly
Cardiology AI
Cleerly ISCHEMIA is an FDA-cleared AI tool that analyzes CCTA scans to non-invasively determine the likelihood of coronary artery ischemia at a vessel level, aiding physicians in personalized diagnosis and treatment planning for heart disease.
Cleerly LABS
Cleerly
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Cleerly LABS is an AI-powered, FDA-cleared web-based software for comprehensive analysis of coronary CT angiography (CCTA) to detect, quantify, and characterize atherosclerosis and stenosis, aiding in personalized heart disease management.

View company profile →

Suggest an Edit → | Report an issue | Last Verified: 2026-09-17 | First Added: 2026-09-17

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