- No public price. The homepage offers a demo request.
- Not disclosed
- Not disclosed
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On this page
39/100Competitive
- Regulatory & Compliance18/28
FDA cleared (6 K-numbers on record)
- Clinical Integration0/26
No EHR integrations listed
- Evidence Strength16.6/26
2 peer-reviewed papers
- Vendor & Market6/18
Early-stage company
- Sentiment & Transparency2.5/14
Pricing on request, no public amounts
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- FDA clearance18/18
FDA cleared (6 K-numbers on record)
- HIPAA / SOC2 / BAA0/10
No public HIPAA/SOC2/BAA attestation
- EHR integrations (count)0/14
No EHR integrations listed
- Top-3 EHR coverage (Epic / Oracle / Athena)0/8
None of the top-3 EHRs covered
- Bidirectional write-back0/4
No bidirectional write-back documented
- Peer-reviewed papers13/18
2 peer-reviewed papers
- RCT / meta-analysis / systematic review4/8
1 observational study (no RCT)
- Funding & adoption signal6/12
Early-stage company
- Years in market0/6
Founded year not recorded
- Clinician sentiment (Reddit)0/9
No clinician sentiment data available
- Pricing transparency3/5
Pricing on request, no public amounts
AI-driven CCTA plaque quantification + CAD staging.
No public price. The homepage offers a demo request.
Bottom line
Cleerly is cloud software that reads coronary CT angiography scans and reports plaque volume, composition, stenosis and ischemia likelihood. It has six FDA 510(k) decisions of substantial equivalence, a Category I CPT code from January 2026, and growing payer coverage. It fits a cardiology or radiology service that already runs coronary CTA and wants quantified plaque in the report. It does not fit a practice without CT access, and the price is available only through sales.
What is Cleerly and who sells it?
Cleerly, Inc. describes its platform as AI-driven software that quantifies atherosclerosis by measuring plaque volume, composition, length and location, and grades stenosis in 2D and 3D, delivered through a web interface (cleerlyhealth.com). Dr. James Min, formerly of Weill Cornell and NewYork-Presbyterian, is the CEO and founder, and the company dates to 2017 (MassDevice). One aggregator says 2016.
Funding is large and the totals vary by source. Reported rounds are a $15M Series A in August 2017, a $43M Series B in 2021, a $223M Series C in July 2022 led by T. Rowe Price and Fidelity, and a $106M extension in December 2024 led by Insight Partners with Battery Ventures. Aggregators put the total at $387M or $578M. Headquarters is reported as New York in older coverage and Denver in newer profiles, including a 2024 journal abstract.
What does it do well?
Its regulatory and reimbursement record is the strongest part. The FDA 510(k) database lists six decisions for Cleerly, Inc., all "substantially equivalent": K190868 (Cleerly Labs, November 2019), K202280 (Labs v2.0, October 2020), K231335 (Cleerly ISCHEMIA, September 2023), K242338 (Cleerly LABS, March 2025), and K260588 and K261210 (Cleerly LABS and Cleerly Plaque, both July 2026). Indications for use are not part of the database record.
The American Medical Association's CPT Category I code 75577 for AI-QCT plaque analysis took effect January 1, 2026, replacing the Category III codes 0623T to 0626T (Cleerly coverage page, Business Wire). Cleerly's press materials say five of seven Medicare Administrative Contractors have finalized coverage policies. Aetna joined UnitedHealthcare, Cigna, Humana, BCBS Kansas City, Excellus BCBS and EviCore as of January 2026, and Aetna requires an FDA-cleared platform. Payment at the new code at the quoted rates is not documented.
On workflow, the vendor lists a PowerScribe integration for reporting and a view of greatest diameter stenosis for reimbursement. It offers serial CCTA comparison to track plaque progression or regression. EHR integrations beyond PowerScribe are not stated.
What does the evidence say?
Cleerly cites its CREDENCE trial for the ISCHEMIA product, claiming higher diagnostic accuracy and area under the curve than FFR-CT and stress testing, measured against 868 invasive fractional flow reserve readings. It also cites a PACIFIC post-hoc analysis in which ISCHEMIA, FFR-CT and PET performed similarly and outperformed SPECT. Both are the vendor's summaries (cleerlyhealth.com).
Two peer-reviewed papers name the software. A 2024 paper in the International Journal of Cardiovascular Imaging (PMID 38630211) uses "FDA-cleared software (Cleerly, Denver, CO)" to compare AI-QCT with visual reads and CAD-RADS. A 2026 paper in the European Journal of Preventive Cardiology (PMID 42054506) uses Cleerly Inc. to study lipoprotein(a) and plaque phenotype. Both use the software as a measurement tool, and neither tests it against another plaque product.
How much does Cleerly cost?
Cleerly sells by quotation. The site offers a demo request, and patient-facing cost and coverage information sits on cleerly.com/costs-coverage. No per-study price is published as of October 2026.
Who is it for?
It fits a cardiac imaging program that reads enough coronary CTA to justify an added analysis step, and one whose payers are on the coverage list. A small practice that sends its CTAs to an outside reader gets Cleerly only if that reader uses it.
The verdict
Buy Cleerly if you run a busy coronary CTA program, your payers cover AI-QCT, and you accept that the accuracy claims come from the vendor. Skip it if you have no CT access or if you need independent head-to-head data against other plaque tools, because none exists in the papers that use the software.
Editorial review last generated October 15, 2026. Synthesized from clinician sentiment, peer-reviewed coverage, and our editorial silo picks. Refined by hand where vendor facts change.
What it costs
All tiers are custom-quoted. The vendor does not publish per-provider list pricing.
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | — | — | No public price. The homepage offers a demo request. |
Source: vendor pricing page. Last checked October 15, 2026.
What deploys cleanly
Carries FDA 510(k) (multiple) per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.
What the literature says
2 peer-reviewed studies indexed on PubMed evaluate Cleerly in clinical contexts. The most relevant are shown below, ranked by editorial relevance score combining title match, study design, recency, and journal tier.
- Assessment of atherosclerotic plaque burden: comparison of AI-QCT versus SIS, CAC, visual and CAD-RADS stenosis categories.
- Khan H, Bansal K, Griffin WF, et al.· Int J Cardiovasc Imaging· 2024
- This study assesses the agreement of Artificial Intelligence-Quantitative Computed Tomography (AI-QCT) with qualitative approaches to atherosclerotic disease burden codified in the multisociety 2022 CAD-RADS 2.0 Expert Consensus. 105 patients who underwent cardiac computed tomography angiography (CCTA) for chest pain were evaluated by a blinded core laboratory through FDA-cleared software (Cleerly, Denver, CO) that performs AI-QCT through artificial intelligence, analyzing factors such as % stenosis, plaque volume, and plaque composition. AI-QCT plaque volume was then staged by recently valid…
- The impact of lipoprotein(a) on coronary atherosclerotic plaque phenotype in primary prevention.
- Verpalen VA, Coerkamp CF, Malkasian S, et al.· Eur J Prev Cardiol· 2026
- Lipoprotein(a) (Lp[a]) is a causal risk factor for cardiovascular events. However, the effect of Lp(a) on coronary plaque composition and high-risk plaque (HRP) features has not been fully characterized. This study aimed to investigate the association between Lp(a) and coronary atherosclerotic plaque phenotype at the plaque level. This study included 710 patients who underwent coronary computed tomography angiography (CCTA) and had Lp(a) measured between 2008 and 2024. CCTA scans were analyzed with a previously validated artificial intelligence-based algorithm (AI-QCT, Cleerly Inc.). The asso…
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