Company Profile / Cardiovascular AI
Cleerly
Putting a number on the plaque that stress tests can't see.
CLEERLY, INC. - THE COMPANY BUILDING A NEW STANDARD OF CARE FOR HEART DISEASE, ONE CORONARY CT AT A TIME.
Putting a number on the plaque that stress tests can't see.
CLEERLY, INC. - THE COMPANY BUILDING A NEW STANDARD OF CARE FOR HEART DISEASE, ONE CORONARY CT AT A TIME.
Cholesterol has a number. Blood pressure has a number. For decades, the plaque actually building up inside a patient's coronary arteries did not. Cleerly's entire premise is to change that.
Cleerly is a digital healthcare company based in Denver, Colorado, that builds FDA-cleared machine-learning software to analyze coronary CT angiography (CCTA) scans. Its algorithms take a routine heart CT and produce a quantitative, vessel-by-vessel picture of coronary artery disease - measuring atherosclerosis (plaque), stenosis, and the likelihood of ischemia without a catheter ever entering the body.
The technology generates a 3D model of a patient's coronary arteries, identifies the lumen and vessel walls, locates and measures narrowings, and then quantifies and categorizes the plaque by volume, composition, length and location. The output is a comprehensive report and an interactive web platform a physician can walk a patient through - turning something invisible into something countable.
"Eliminate heart attacks by creating a new standard of care for heart disease."
Why do so many heart attacks happen in arteries that a stress test just called "normal"?
Cleerly was founded in 2017 by James K. Min, MD, a cardiologist who had spent years watching functional testing miss disease that was plainly visible in the artery wall. The company's science traces back to a coronary CT research program Min began around 2003 at NewYork-Presbyterian / Weill Cornell Medicine.
That academic lineage is the company's core asset. Cleerly's algorithms were developed and validated using millions of medical images from tens of thousands of patients, drawing on landmark multi-center trials including CREDENCE, PACIFIC, CONFIRM and CONFIRM2. Cleerly ISCHEMIA, its per-vessel ischemia estimate, was calibrated against invasive FFR - the catheter-based gold standard the software is designed to help patients avoid.
"We are thrilled to receive this investment from Insight Partners, marking a significant milestone for Cleerly."
The core platform. It ingests a CCTA study, builds a 3D model of the coronary arteries, finds the lumen and vessel walls, locates stenoses, and quantifies and categorizes plaque by volume, type, length and location.
A first-of-its-kind, FDA 510(k)-cleared decision-support tool that uses 37 measures of heart health to estimate the likelihood of coronary ischemia at a per-vessel level - a non-invasive signal calibrated to invasive FFR.
A comparative tool that tracks disease progression or regression across serial scans, turning coronary artery disease into a condition that can be monitored and managed over time.
Who it serves. Cleerly sells to hospitals, health systems, and cardiology and imaging practices - and, through them, to the patients who arrive for a coronary CT. A physician orders Cleerly on a patient's CCTA and receives back a quantitative report and interactive review.
The problem. Traditional workups often infer heart disease from blood flow or symptoms and can miss the non-obstructive plaque that causes many heart attacks. Invasive angiography answers the question directly but requires a catheter. Cleerly aims for a middle path: measure the disease itself, non-invasively.
Most rivals model blood flow. Cleerly's bet is on the plaque itself - and on the unglamorous plumbing of reimbursement.
The nearest comparison is HeartFlow, whose FFR-CT technology estimates blood flow through a coronary artery. Cleerly instead focuses on directly quantifying and characterizing the plaque burden - the atherosclerosis that drives disease - while also offering its ISCHEMIA estimate. Other players in and around the space include Elucid, Caristo Diagnostics and Nanox AI, alongside the incumbents Cleerly hopes to displace: stress testing, coronary calcium scoring and invasive angiography.
In healthcare AI, the algorithm is rarely the hard part - getting it cleared, coded and covered is. Cleerly has quietly assembled all three: FDA 510(k) clearance for ISCHEMIA in January 2024, a Category I CPT code, Medicare coverage, and commercial coverage from Aetna. That reimbursement scaffolding is what turns a clever scan into a billable standard of care.
Cleerly operates as a B2B software-as-a-medical-device business. Providers pay per analysis or via subscription, and the company monetizes through the clinical reimbursement pathways it has secured. Investors have backed that model heavily - Cleerly has raised more than $500 million across multiple rounds.
The 2022 Series C was led by T. Rowe Price and Fidelity, with earlier backing from Novartis, Cigna Ventures and Peter Thiel. In December 2024, Insight Partners led a $106M Series C extension - joined by Battery Ventures - to scale commercial growth and clinical evidence generation.
James Min starts a coronary CT research program at NewYork-Presbyterian / Weill Cornell Medicine that will later underpin Cleerly.
Min founds Cleerly in Denver to commercialize AI-based coronary plaque analysis.
The company emerges publicly with early funding and its CCTA plaque-analysis platform.
An oversubscribed round led by T. Rowe Price and Fidelity supercharges commercialization and evidence generation.
The company receives 510(k) clearance for its per-vessel AI ischemia estimate and closes a $106M Series C extension led by Insight Partners.
Explore Cleerly's product explainers, demos and interviews:
Cleerly makes FDA-cleared AI software that analyzes coronary CT angiography scans to non-invasively measure plaque, stenosis and the likelihood of ischemia in the heart's arteries, helping physicians diagnose and manage coronary artery disease.
Cleerly was founded in 2017 by cardiologist James K. Min, MD, who serves as CEO. Its science traces back to a research program he began around 2003 at Weill Cornell Medicine.
Cleerly has raised more than $500 million across multiple rounds, including a $223M Series C in 2022 and a $106M Series C extension led by Insight Partners in December 2024.
Yes. Cleerly ISCHEMIA received FDA 510(k) clearance in January 2024, and the company has secured Medicare coverage, a Category I CPT code, and commercial coverage from payers such as Aetna.
Instead of inferring problems from blood flow or symptoms, Cleerly directly measures and quantifies the plaque in each coronary artery from a CT scan, aiming to catch disease that functional tests can miss.