Cleerly COMPARE
Longitudinal tracking of coronary plaque progression and treatment response
Software · Cloud SaaSCompany source
Company profile
About Cleerly
Cleerly is a comprehensive, AI-driven platform that quantifies and assesses coronary artery disease (CAD) to deliver clinically actionable insights through a web-based solution. The company's software leverages machine learning to analyze coronary computed tomography angiography (CCTA) scans, providing detailed measurements of atherosclerosis including plaque volume, composition, length, and location. Cleerly evaluates stenosis severity in both 2D (diameter and area) and 3D (lumen and vessel volume) formats, with an integrated workflow for determining the likely presence or absence of ischemia. The platform aims to reduce the need for additional testing while enhancing diagnostic confidence for healthcare providers. Cleerly's product suite includes Cleerly Plaque Analysis, Cleerly ISCHEMIA, and Cleerly COMPARE, serving healthcare providers, health systems, and payors. The company's technology has been validated through clinical trials including the prospective, multicenter CREDENCE trial, where Cleerly ISCHEMIA demonstrated higher diagnostic accuracy compared to FFRCT and stress testing when referenced against invasive fractional flow reserve (FFR) measurements. In the PACIFIC study post-hoc analysis, Cleerly ISCHEMIA was the only non-invasive ischemia test that was prognostic of future major adverse cardiac events (MACE). The platform provides comprehensive, accurate, and trackable insights to personalize treatment decisions and improve patient outcomes in cardiac care.
Company description Cleerly official website
Primary marketCardiology & Cardiovascular Health
Commercial modelCommercial information available on request
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01 · Operating footprint
Where the Company operates
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
Clinical focus
- atherosclerosis
- Coronary Artery Disease (CAD)
- coronary stenosis
- heart attack prevention
- myocardial ischemia
Who it serves
- Health Systems
- Healthcare Providers
- Payors
- Providers
Deployment & integration
Cloud Saas deployment with recorded integration context.
Geographic context
MarketsNot currently listed
Company sourceOfficial website
Company milestones
Platform expansion
New commercial insurance coverage announced. Category I CPT code approval for clinical billing.
Partnerships
Recorded partners
No partners are currently listed.
02 · Flagship portfolio
Products, workflows, and platform capabilities
Selected source-backed Company products and the available commercial context.
Cleerly ISCHEMIA
AI-powered detection of likely ischemia in coronary vessels
Software · Cloud SaaSCompany source
Cleerly Plaque Analysis
AI-driven quantification and assessment of coronary artery disease plaque
Software · Cloud SaaSCompany source
03 · Research intelligence
Research Intelligence evidence
Publications, preprints, clinical validation, and regulatory records in Evidence Position order.
Evidence position
Publications, clinical validation, and regulatory records connected to this Company appear here.
Research
Publications & preprints
Health Status Relationship to Ischemia and Coronary Artery Disease Severity in the ISCHEMIA Trial.American heart journal · Aug 25, 2026
Association of Low-Attenuation Noncalcified Plaque Shape and Degree of Intraplaque Embeddedness Using Atherosclerotic Imaging-enabled Quantitative CT with Acute Coronary Syndrome.Radiology. Cardiothoracic imaging · Aug 1, 2026
Prediction of the Statin responders with radiomics.Journal of cardiovascular computed tomography · Jun 4, 2026
Hepatic Steatosis Is Associated With Increased Cardiovascular Risk Through Adverse Coronary Plaque Composition.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · May 20, 2026
Longitudinal Data from the KETO-CTA Study: Plaque Predicts Plaque, ApoB Does Not: JACC Adv. 2025;4(7):101686.JACC. Advances · May 1, 2026
Lipoprotein(a) selectively associates with vulnerable coronary plaque phenotypes in comparison with other established risk markers.European heart journal. Cardiovascular Imaging · Apr 30, 2026
Clinical validation
Clinical-trial records
A Randomized Comparison of Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardiovascular EventsNCT06112418 · Sponsor · RECRUITING
Measuring Athlete's Risk of Cardiovascular Events 3 (MARC-3)NCT07625488 · Sponsor · ENROLLING BY INVITATION
Coronary CT Angiography Evaluation for Clinical Outcomes: An International Multicenter RegistryNCT04279496 · Sponsor · ENROLLING BY INVITATION
A Randomized Comparison of Personalized Therapy Mgmt Based On Coronary Atherosclerotic Plaque Vs. Usual Care for Symptomatic Patients With Suspicion of CADNCT06713239 · Sponsor · ACTIVE NOT RECRUITING
ProActive Athlete Heart Program: Proposal for Cardiac Risk Screening in Former High-Intensity AthletesNCT07460583 · Sponsor · NOT YET RECRUITING
Heart CT Imaging to Detect Early Coronary Artery Disease in First-Degree Relatives With High or Low Lipoprotein(a) Identified Through Family ScreeningNCT06995183 · Mentioned · RECRUITING
Regulatory
Regulatory records
Cleerly LABS (v2.0)K242338 · 510k · Mar 7, 2025
Cleerly ISCHEMIAK231335 · 510k · Sep 8, 2023
Cleerly Labs v2.0K202280 · 510k · Oct 2, 2020
Cleerly LabsK190868 · 510k · Nov 5, 2019
04 · Company-reported outcomes
Outcomes and case studies
Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.
Higher diagnostic accuracy compared to FFRCT and stress testing
CREDENCE trial with invasive FFR as reference standard
Prognostic of future MACE events
Only non-invasive ischemia test with prognostic value in PACIFIC study multivariate analysis
Similar performance to FFRCT and PET in predicting ischemia
Per-patient basis in PACIFIC study, outperformed SPECT
Potentially reduces need for additional testing
Enhanced diagnostic confidence through comprehensive analysis
MemorialCare Heart & Vascular Institute
First hospital in Los Angeles County to implement Cleerly AI-powered heart disease analysis for quantifying total plaque volume and soft plaque across multiple facilities
Systemwide launch across Long Beach Medical Center, Orange Coast Medical Center, and additional facilities
CERTAIN Study participants
Impact of AI-QCT on diagnostic certainty, downstream testing, coronary revascularization, and medical therapy
Improved diagnostic certainty, reduced downstream need for non-invasive testing, and increased rates of preventive medical therapy
CONFIRM2 Registry participants
10-year follow-up study demonstrating prognostic value of AI-QCT plaque staging for MACE prediction
AI-QCT plaque staging showed important prognostic value for MACE and additional discriminatory value over clinical risk factors, CACS, and manual CCTA assessment
CREDENCE Trial (Multicenter)
Validation of Cleerly ISCHEMIA diagnostic accuracy for detecting ischemia compared to FFRCT and stress testing
Higher diagnostic accuracy and area under the curve compared to FFRCT and stress testing, referenced to 868 invasive FFR measurements
PACIFIC Trial
Comparison of Cleerly ISCHEMIA performance against FFRCT, PET and SPECT for predicting ischemia and MACE events
Cleerly ISCHEMIA was the only non-invasive ischemia test prognostic of future MACE events; performed similarly to FFRCT and PET in predicting invasive FFR≤0.8
05 · Leadership
Leadership team
Leadership profiles and professional links from the current Company record.
James K. Min
Founder & CEO
Udo Hoffmann
Chief Medical, Scientific and AI Officer
Jim Hartman
Chief Commercial Officer
Kimberly McCombs
Chief Strategy Officer
Parker Cassidy
Chief Operating Officer
Andrew Levitch
Chief Financial Officer
Amit Relia
Chief Regulatory Officer
Christine Pellizzari
Chief Legal Officer
06 · Company updates
Updates from Cleerly
Recent articles published on Cleerly's official website.
The Recipe to a Healthy Heart: Your Guide to Heart Disease Prevention
Read on CleerlyThe Recipe to a Healthy Heart: Your Guide to Preventing Heart Disease
Read on CleerlyThe Recipe to a Healthy Heart: Your Guide to Preventing Heart Disease
Read on Cleerly2023 in Review: Recognition, Growth, Continuous Innovation at Cleerly
Read on Cleerly2023 in Review: Recognition, Growth, Continuous Innovation at Cleerly
Read on Cleerly07 · HAIC coverage
Coverage and analysis
Health AI Central reporting that mentions this Company.
No HAIC coverage is currently linked to this Company.
08 · Official presence
Company sources and channels
Curated official destinations from the active Company record.
09 · Market pathway
Additional Companies in this Market
Other active Companies in the same market, selected alphabetically from the HAIC directory.
Market context
Cardiology & Cardiovascular Health
Companies applying AI to cardiovascular disease detection, ECG/EKG analysis, heart failure management, cardiac imaging, arrhythmia detection, or cardiovascular risk assessment. Includes AI-powered cardiac diagnostics, non-invasive hemodynamic monitoring, and tools for early detection and personalized management of heart conditions.
Explore the full market directory or compare this Company with additional active profiles.
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Linked research, clinical, and regulatory source pathways.
Expanded product, deployment, integration, and partnership research.
Record-level provenance and review context.