Clinical systems · AI coronary plaque analysis
Cleerly
Cleerly is a cardiac imaging company founded in 2017 by cardiologist James K. Min whose FDA-cleared AI software measures and characterizes coronary artery plaque, including non-calcified plaque, on coronary CT angiography scans to help doctors stage heart disease and guide treatment.
Strong fit
- Cardiology groups and imaging centers that already run coronary CT angiography for chest pain
- Preventive cardiology programs that want plaque volume and type, beyond a calcium score
- Health systems that want to bill the Category I CPT code for AI plaque analysis
Weak fit
- Practices without a cardiac-capable CT scanner or a CT angiography program
- Clinics that only order calcium scores and stress tests for risk checks
- Teams that want a screening program for people without symptoms that payers already cover
Bottom line
Cleerly turns a coronary CT angiography scan into a measured report of plaque volume, plaque type, and narrowing, which helps cardiologists decide how hard to treat a patient. It is worth using for cardiology and imaging groups with an active CT angiography program, now that Medicare covers AI plaque analysis for patients with symptoms. Its larger goal of screening people without symptoms depends on the TRANSFORM trial, with results expected in 2029.
Score breakdown
Weights: Outcomes 35% · Product 30% · Implementation 20% · Pricing clarity 15%.
Cleerly is used by cardiologists, radiologists, and imaging centers that perform coronary CT angiography, a dye-enhanced CT scan of the heart arteries. The scan goes to Cleerly's software, which measures the plaque in each artery, separates calcified plaque from softer non-calcified plaque, and grades narrowing. The output is a report that stages coronary artery disease, which doctors use to decide on statins, other drugs, or more testing. A calcium score only shows hard plaque, and Cleerly's product material stresses that its analysis also captures non-calcified plaque.
The best use today is patients with chest pain or other symptoms. Medicare approved coverage for Cleerly's plaque analysis in October 2024, as TechCrunch reported, and the American Medical Association has approved a Category I CPT code for AI plaque analysis, according to Cardiovascular Business. Cleerly's closest competitors are HeartFlow and Elucid, which also analyze coronary CT scans with AI. On price, Cleerly is paid per analyzed scan, and the CPT code and Medicare coverage let imaging providers bill payers for that analysis.
The open question is screening people without symptoms. Cleerly is running TRANSFORM, a randomized trial at 125 US sites that tests whether treatment guided by its disease staging prevents more heart attacks than care based on standard risk factors. Its October 2026 update says primary results are expected in 2029. Until then, the screening case rests on observational research.
Cleerly was founded in 2017 by James K. Min, a former Weill Cornell professor and director of the Dalio Institute of Cardiovascular Imaging, and has raised a $223 million Series C and a $106 million Series C extension led by Insight Partners. It does not publish revenue. Its revenue is an estimated $50 million a year, based on more than four years of sales growing over 100% a year, payer coverage for symptomatic patients, and its funding size. In April 2026 HeartFlow sued Cleerly for patent infringement, and Cleerly said in a public statement that it will defend the case.
What doctors and buyers say
What people like
"We already do CT angiography for chest pain, and now the report tells us how much soft plaque is there, which a calcium score never showed us."
"Having a CPT code and Medicare coverage made it much easier to get the plaque analysis approved by our finance team."
What people don't like
"If your hospital cannot do coronary CTA, Cleerly does nothing for you, and plenty of rural sites still cannot."
"We like the staging, but the big screening study will not report until 2029, so treating people without symptoms off it is still a judgment call."
Where customer reviews couldn't be found, our analysts attempted to give a voice to buyer sentiment, drawing on real information from review sites, forums and product documentation.
Based on: TechCrunch on Cleerly's funding and Medicare coverage, Cardiovascular Business interview with James Min, TRANSFORM mobile CT update, and Cleerly and Allelica release.
Pricing
| Item | Detail |
|---|---|
| Model | Per-study AI analysis of coronary CT angiography scans, sold to hospitals, imaging centers, and cardiology groups. |
| Reimbursement | Medicare coverage for AI plaque analysis in patients with symptoms since October 2024, and a Category I CPT code approved by the American Medical Association. |
| Other products | The Cleerly Polygenic Cardiovascular Risk Score Test, a saliva-based genetic test run in a CLIA-certified lab, launched in July 2026. |
| What drives cost | Study volume, which Cleerly products are used, and integration with the imaging system. |
Leadership
James K. Min, MDFounder and CEO- Udo Hoffmann, MD, MPHChief Medical, Scientific, and AI Officer
- Michal SofkaChief Technology Officer
Recent news
- October 2026: The FDA cleared an updated version of Cleerly LABS and a new PLAQUE algorithm trained on CONFIRM2 registry data from 6,550 people in 46 countries, about half of them women. The update reaches customers in November 2026.
- October 2026: Cleerly and Clear Heart and Lung Imaging took a mobile cardiac CT scanner through Arizona, Louisiana, Georgia, and Florida from July to September so patients in areas without cardiac CT could join the TRANSFORM trial.
- July 2026: Cleerly and Allelica launched a polygenic risk score test for coronary artery disease, which doctors can order alone or with Cleerly's CT analysis.
- April 2026: HeartFlow filed a patent infringement lawsuit against Cleerly, which called the claims baseless and said customer service would not be interrupted.
Methodology
| Weight | Factor | What it measures |
|---|---|---|
| 35% | Customer outcomes | Whether buyers get measurable operational or clinical-workflow results after go-live |
| 30% | Product | Capability depth, reliability, and fit for the job the category buys |
| 20% | Implementation | How hard it is to stand up, integrate, train, and stabilize |
| 15% | Pricing clarity | Whether a buyer can model total cost without a mystery quote |
| Label | Meaning |
|---|---|
| Highly recommend | Strong outcomes and product with manageable caveats |
| Recommend | Solid fit for the right buyer; know the tradeoffs |
| Conditional | Only with a specific use case or heavy caveats |
| Not recommended | Avoid for most buyers in this category |
Read our full methodology for how we weight scores and assign recommend labels.