Cleerly

Cleerly uses AI to analyze coronary CT angiography scans to quantify and characterize atherosclerotic plaque, enabling personalized heart attack risk assessment. Raised $250M+ including $192M Series C. FDA-cleared. Multiple CPT Category III codes established. CMS coverage underway. Published strong clinical evidence.

Cleerly is building the standard for AI-based coronary artery disease screening — a category that could redefine cardiac preventive care with imaging-based risk stratification replacing population-based risk scores.

cleerlyhealth.com Imaging & Diagnostics AI

United Statesprivate

At a glance

Total raised

$372M

last round series c

Headcount

201-500

approximate · public range

Headquarters

Denver

United States

Founded

2017

9 years active

Status

Private

Imaging & Diagnostics AI

Patents on file

USPTO grants

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Funding history

Total raised

$372M

Rounds tracked

Latest stage

Series C

Date	Stage	Amount	Valuation	Lead investors
Dec 4, 2024	Series C	$106M	—	Insight Partners
Jul 25, 2022	Series C	$223M	—	T. Rowe Price, Fidelity
Jun 21, 2021	Series B	$43M	—	Vensana Capital

Founder backgrounds

James K. Min, MD

Founder & CEO

Earned a BA from the University of Chicago and an MD from Temple University School of Medicine. Spent over a decade in academic medicine, most recently as a Professor of Radiology and Medicine (Cardiology) at Weill Cornell Medical College and Director of the Dalio Institute of Cardiovascular Imaging at NewYork-Presbyterian Hospital. Prior to that, he was at UCLA. He served as President of the Society of Cardiovascular Computed Tomography and as Editor-in-Chief of the *Journal of Cardiovascular Computed Tomography*, and led the core lab for major multicenter trials including ISCHEMIA and PACIFIC. While at Weill Cornell, his research showed that AI-powered coronary plaque analysis could outperform standard care — but doing it manually was too labor-intensive to scale. That insight led him to leave academia and found Cleerry, automating what he'd spent years proving worked.

AI bull / bear

Bull case

Cleerly is positioned to capture a massive whitespace in cardiac diagnostics by making CT-based plaque analysis the standard for coronary risk assessment. With $372M in total funding and backing from Insight Partners, the company has the balance sheet to outlast competitors while CMS coverage is finalized. Once national coverage is secured—momentum is already building—reimbursement unlocks a scalable commercial flywheel. The clinical evidence is the real moat: Cleerly has published data showing its AI can quantify non-calcified plaque with precision that traditional calcium scoring and population-based risk models miss, directly linking imaging biomarkers to cardiac event risk. The multiple CPT Category III codes already established mean the procedural infrastructure exists; payers just need to follow. As preventive cardiology shifts toward imaging-based risk stratification, Cleerly owns the first-mover advantage in a category where regulatory clearance and clinical validation cycles create multi-year barriers for any challenger.

Bear case

Cleerly faces a reimbursement bottleneck that could stall commercial adoption for years. CPT Category III codes are temporary tracking codes, not permanent Category I codes—they signal interest, not guaranteed payment. CMS coverage is directional but not secured, and even if achieved, national coverage determinations often come with restrictive clinical indications that limit the addressable market. On the competitive side, Cleerly is burning cash against imaging giants like Siemens Healthineers and GE HealthCare, both of whom are embedding AI plaque analysis into their own scanner ecosystems and already own the radiology workflow. The $372M raised also sets a high bar for exit—likely IPO—and without clear revenue traction, public markets may balk. There is also a real adoption-friction problem: convincing cardiologists and radiologists to replace familiar population-based risk calculators with a CT-based AI workflow requires changing clinical guidelines, which moves at the speed of medical consensus, not venture capital.

Generated by deepseek-v4-pro · May 2, 2026Refreshes quarterly · see disclosures

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Leadership

James K. Min, MD

Founder & CEO

Jim Hartman

Chief Commercial Officer

—

Dr. Udo Hoffmann, MD, MPH

Chief Medical, Scientific and AI Officer

—

Kimberly McCombs

Chief Strategy Officer

—

Amit Relia

Chief Regulatory Officer

—

Andrew Levitch

Chief Financial Officer

—

Michal Sofka

Chief Technology Officer

—

Products

Cleerly LABS
An AI-powered, FDA-cleared platform that analyzes coronary CT angiography (CCTA) scans to non-invasively quantify and characterize atherosclerotic plaque. It measures stenosis severity, plaque volume, and plaque composition (e.g., calcified, non-calcified, low-attenuation), generating a 3D model of the patient's coronary arteries. Designed for cardiologists and radiologists, Cleerly LABS provides a comprehensive, automated analysis that helps clinicians assess coronary artery disease with higher accuracy than traditional expert reading.
Cleerly ISCHEMIA
A lesion-specific ischemia assessment module that uses AI to determine the likelihood of ischemia (blood-flow obstruction) in individual coronary vessels. By combining plaque characterization data with patient-specific metrics, Cleerly ISCHEMIA estimates the hemodynamic significance of each stenosis, helping interventional cardiologists decide which lesions warrant revascularization. It aligns with professional guideline thresholds and offers a non-invasive alternative to invasive FFR measurements.
Cleerly COMPARE
A longitudinal comparison tool that enables physicians to track changes in a patient's coronary plaque burden and composition over time across sequential CCTA scans. It overlays quantitative measurements from prior and current analyses to visualize disease progression or regression, supporting data-driven decisions about treatment efficacy and medication adjustments. This is especially valuable for managing patients with known coronary artery disease who require ongoing monitoring.
Cleerly PREVIEW
A workflow-support enhancement to Cleerly's AI-enabled quantitative CT platform, designed to streamline clinical reading workflows. PREVIEW provides pre-processed, prioritized views and automated case preparation so radiologists and cardiologists can review AI findings more efficiently. Launched in early 2026, it aims to reduce interpretation time while maintaining diagnostic confidence, making AI-powered plaque analysis more practical for high-volume clinical settings.

Most recent patents

CLEERLY, INC.·2026-02-24
Systems, Methods, And Devices For Medical Image Analysis, Diagnosis, Risk Stratification, Decision Making And/Or Disease Tracking
US12558048
Abstract
Systems, Methods, And Devices For Medical Image Analysis, Diagnosis, Risk Stratification, Decision Making And/Or Disease Tracking
US12558048
The disclosure herein relates to systems, methods, and devices for medical image analysis, diagnosis, risk stratification, decision making and/or disease tracking. In some embodiments, the systems, devices, and methods described herein are configured to analyze non-invasive medical images of a subject to automatically and/or dynamically identify one or more features, such as plaque and vessels, and/or derive one or more quantified plaque parameters, such as radiodensity, radiodensity composition, volume, radiodensity heterogeneity, geometry, location, and/or the like. In some embodiments, the systems, devices, and methods described herein are further configured to generate one or more assessments of plaque-based diseases from raw medical images using one or more of the identified features and/or quantified parameters.
View on Google Patents
CLEERLY, INC.·2026-02-17
Systems, Methods, And Devices For Medical Image Analysis, Diagnosis, Risk Stratification, Decision Making And/Or Disease Tracking
US12555228
Abstract
Systems, Methods, And Devices For Medical Image Analysis, Diagnosis, Risk Stratification, Decision Making And/Or Disease Tracking
US12555228
The disclosure herein relates to systems, methods, and devices for medical image analysis, diagnosis, risk stratification, decision making and/or disease tracking. In some embodiments, the systems, devices, and methods described herein are configured to analyze non-invasive medical images of a subject to automatically and/or dynamically identify one or more features, such as plaque and vessels, and/or derive one or more quantified plaque parameters, such as radiodensity, radiodensity composition, volume, radiodensity heterogeneity, geometry, location, perform computational fluid dynamics analysis, facilitate assessment of risk of heart disease and coronary artery disease, enhance drug development, determine a CAD risk factor goal, provide atherosclerosis and vascular morphology characterization, and determine indication of myocardial risk, and/or the like. In some embodiments, the systems, devices, and methods described herein are further configured to generate one or more assessments of plaque-based diseases from raw medical images using one or more of the identified features and/or quantified parameters.
View on Google Patents
Cleerly, Inc.·2025-10-14
Systems, Devices, And Methods For Non-Invasive Image-Based Plaque Analysis And Risk Determination
US12440180
Abstract
Systems, Devices, And Methods For Non-Invasive Image-Based Plaque Analysis And Risk Determination
US12440180
Various embodiments described herein relate to systems, devices, and methods for non-invasive image-based plaque analysis and risk determination. In particular, in some embodiments, the systems, devices, and methods described herein are related to analysis of one or more regions of plaque, such as for example coronary plaque, using non-invasively obtained images that can be analyzed using computer vision or machine learning to identify, diagnose, characterize, treat and/or track coronary artery disease.
View on Google Patents
Cleerly, Inc.·2025-09-02
Systems, Devices, And Methods For Non-Invasive Image-Based Plaque Analysis And Risk Determination
US12406365
Abstract
Systems, Devices, And Methods For Non-Invasive Image-Based Plaque Analysis And Risk Determination
US12406365
Systems and methods of facilitating determination of risk of coronary artery disease (CAD) based at least in part on one or more measurements derived from non-invasive medical image analysis. The methods can include accessing a non-invasive generated medical image, identifying one or more arteries, identifying, regions of plaque within an artery, analyzing the regions of plaque to identify low density non-calcified plaque, non-calcified plaque, or calcified plaque based at least in part on density, determining a distance from identified regions of low density non-calcified plaque to one or more of a lumen wall or vessel wall, determining embeddedness of the regions of low density non-calcified plaque by one or more of non-calcified plaque or calcified plaque, determining a shape of the more regions of low density non-calcified plaque, and generating a display of the analysis to facilitate determination of one or more of a risk of CAD of the subject.
View on Google Patents
Cleerly, Inc.·2025-08-05
Systems, Methods, And Devices For Image-Based Plaque Analysis And Risk Determination
US12380560
Abstract
Systems, Methods, And Devices For Image-Based Plaque Analysis And Risk Determination
US12380560
This application is directed to systems, methods, and devices for image based analysis of plaque. In some embodiments, the approaches herein can be used for developing treatment plans, which can include local treatment, systemic treatment, or both. In some embodiments, the approaches herein can be used for stent selection. In some embodiments, the approaches herein can be used for surgical planning, which can include robotic surgical planning. In some embodiments, the approaches herein can be used for image normalization. In some embodiments, the approaches herein can be used for identifying plaque calcification thresholds. In some embodiments, the approaches herein can be used for identifying thin cap fibroatheroma. In some embodiments, the approaches herein can be used for coronary artery tree reconstruction. Some embodiments are directed to coronary artery disease risk stratification.
View on Google Patents
Cleerly, Inc.·2025-06-10
Systems, Devices, And Methods For Non-Invasive Image-Based Plaque Analysis And Risk Determination
US12324696
Abstract
Systems, Devices, And Methods For Non-Invasive Image-Based Plaque Analysis And Risk Determination
US12324696
Various embodiments described herein relate to systems, devices, and methods for non-invasive image-based plaque analysis and risk determination. In particular, in some embodiments, the systems, devices, and methods described herein are related to analysis of one or more regions of plaque, such as for example coronary plaque, using non-invasively obtained images that can be analyzed using computer vision or machine learning to identify, diagnose, characterize, treat and/or track coronary artery disease.
View on Google Patents
Cleerly, Inc.·2024-12-31
Systems, Methods, And Devices For Medical Image Analysis, Diagnosis, Risk Stratification, Decision Making And/Or Disease Tracking
US12178627
Abstract
Systems, Methods, And Devices For Medical Image Analysis, Diagnosis, Risk Stratification, Decision Making And/Or Disease Tracking
US12178627
The disclosure herein relates to systems, methods, and devices for medical image analysis, diagnosis, risk stratification, decision making and/or disease tracking. In some embodiments, the systems, devices, and methods described herein are configured to analyze non-invasive medical images of a subject to automatically and/or dynamically identify one or more features, such as plaque and vessels, and/or derive one or more quantified plaque parameters, such as radiodensity, radiodensity composition, volume, radiodensity heterogeneity, geometry, location, and/or the like. In some embodiments, the systems, devices, and methods described herein are further configured to generate one or more assessments of plaque-based diseases from raw medical images using one or more of the identified features and/or quantified parameters.
View on Google Patents
Cleerly, Inc.·2024-12-24
Systems, Methods, And Devices For Medical Image Analysis, Diagnosis, Risk Stratification, Decision Making And/Or Disease Tracking
US12171606
Abstract
Systems, Methods, And Devices For Medical Image Analysis, Diagnosis, Risk Stratification, Decision Making And/Or Disease Tracking
US12171606
The disclosure herein relates to systems, methods, and devices for medical image analysis, diagnosis, risk stratification, decision making and/or disease tracking. In some embodiments, the systems, devices, and methods described herein are configured to analyze non-invasive medical images of a subject to automatically and/or dynamically identify one or more features, such as plaque and vessels, and/or derive one or more quantified plaque parameters, such as radiodensity, radiodensity composition, volume, radiodensity heterogeneity, geometry, location, and/or the like. In some embodiments, the systems, devices, and methods described herein are further configured to generate one or more assessments of plaque-based diseases from raw medical images using one or more of the identified features and/or quantified parameters.
View on Google Patents

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