Cleerly vs Heartflow (2026)
Both estimate whether a coronary narrowing limits flow, by different methods, and both quantify plaque. Heartflow's FFRCT simulates flow from a 3D model of the arteries; it was first authorized in 2014 and validated against invasive FFR in the prospective HeartFlowNXT study, with the PRECISE randomized trial and the DECIDE registry behind the platform. Cleerly ISCHEMIA estimates vessel level ischemia as a diagnostic aid, validated in the prospective, multicenter CREDENCE trial. Cleerly publishes its SOC 2 Type 2 and HITRUST reports for download; Heartflow names its certifications and provides reports on request. Heartflow's plaque and roadmap functions are cleared in the US but not in Europe, the UK, Australia, Canada or Japan. If lesion level physiology is the decision, start with Heartflow. If plaque characterization with an ischemia estimate is, and you want the security reports open, start with Cleerly.
- Plaque characterization is the question: Cleerly Labs measures plaque volume, composition, length and location on CT from any scanner.
- You want an ischemia estimate with counts: K231335 reports per vessel sensitivity of 75.9 percent (167 of 220) and specificity of 83.4 percent (521 of 625) across 582 patients.
- You want the security reports open: the trust center offers SOC 2 Type 2 and HITRUST reports for download without a request.
- Physiology is the decision: FFRCT estimates the physiological significance of each lesion, validated against invasive FFR in the prospective, multicenter HeartFlowNXT study.
- You want trial evidence on the pathway: the PRECISE randomized trial, the ADVANCE registry and the DECIDE registry of about 22,000 patients.
- You want the limits stated: the indications page names the populations the analysis was not evaluated in, and trained Case Analysts work on each model.
This comparison is published by AI Health Index, an independent research platform that compares healthcare AI vendors objectively. Cleerly and Heartflow are each graded against the same capability taxonomy, from each vendor's own public materials and the regulatory record, under the AI Health Index verification standard. No vendor pays for placement, and no vendor has reviewed this page. How this evidence is graded
Plain facts
| Fact | Cleerly | Heartflow |
|---|---|---|
| Primary category | Radiology & Imaging AI | Radiology & Imaging AI |
| Founded | 2017 | 2007 |
| Headquarters | Denver, Colorado, United States | Mountain View, California, United States |
| Website | cleerlyhealth.com | heartflow.com |
Side by Side
Select any grade to read the note behind it.
Each vendor in one paragraph
Written to be quoted whole. Each paragraph opens the AI Health Index profile of the vendor: what the product is, who buys it and what it does.
Cleerly applies AI to coronary CT angiography to quantify and characterize atherosclerotic plaque and estimate ischemia without an invasive test. Cleerly Labs, web based analysis cleared in 2020, measures plaque volume, composition, length and location and stenosis on CCTA from any scanner; Cleerly ISCHEMIA, cleared in 2023 (K231335), estimates vessel level ischemia as a diagnostic aid; Cleerly COMPARE tracks change between scans.
Source: AI Health Index, September 2026
Heartflow created non-invasive coronary physiology from CT. Its Heartflow One platform analyzes a coronary CT angiogram a hospital has already acquired: Roadmap Analysis for stenosis, FFRCT Analysis for the physiological significance of each lesion, simulated from a 3D model of the coronary arteries, Plaque Analysis and plaque staging, and PCI Navigator for planning intervention, now in routine use at The Valley Hospital.
Source: AI Health Index, September 2026
Questions buyers ask
How do Cleerly and Heartflow work with the EHR?
Cleerly operates as a CCTA analysis service that returns a physician report, sitting in the cardiac imaging and reporting pathway rather than integrating deeply with the EHR.
Heartflow describes CT studies sent securely to it without manual export and results returned into both PACS and the electronic record, with a support team that deploys the software and integrates it with PACS, record and other hospital systems. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 27, 2026. No vendor pays for placement.
How are Cleerly and Heartflow priced and sold?
Cleerly publishes billing guidelines, coverage pages and a payer policy lookup tool: AI plaque analysis of coronary CT carries Category I CPT code 75577 from January 2026, ISCHEMIA is billable under Category I code 75580, and Medicare contractor and commercial payer policies are reported to cover more than 86 million lives.
Heartflow publishes reimbursement resources and a market access value dossier. The dossier records a Category I CPT pathway for AI plaque analysis of coronary CT, CMS payment for plaque analysis as a separate outpatient hospital service, a July 2025 EviCore coverage recommendation for Plaque Analysis, and states frankly that current reimbursement does not adequately pay for FFRCT. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 27, 2026. No vendor pays for placement.
Which settings and specialties do Cleerly and Heartflow cover?
Cleerly Labs analyzes CCTA from any CT scanner for patients with known or suspected coronary artery disease, and ISCHEMIA estimates vessel level ischemia as a diagnostic aid; COMPARE tracks change between scans. ISCHEMIA was validated in stable patients referred for non-emergent invasive angiography at 23 centers in and outside the US, with results reported for both.
In Heartflow's case, the intended use covers adults 22 and over with suspected coronary artery disease (the combined analysis) and clinically stable symptomatic patients (FFRCT), and FFRCT's performance was validated in patients who were candidates for invasive angiography, with CT acquired within 60 days of invasive FFR. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 27, 2026. No vendor pays for placement.
What evidence is published for Cleerly and Heartflow?
For Cleerly, a post-hoc analysis of the PACIFIC trial compared it with FFRCT, PET and SPECT against invasive FFR, and the international CONFIRM2 registry links quantified plaque burden to risk. The company's claims that ISCHEMIA was more accurate than FFRCT and stress testing and was the only non-invasive ischemia test prognostic of later events come from its own analyses of CREDENCE and PACIFIC.
With Heartflow, the company's indications page summarizes performance as 84 percent accurate, 82 percent sensitive and 85 percent specific. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 27, 2026. No vendor pays for placement.
Related comparisons
Other published head to head assessments involving these vendors or their closest peers. The full set for this category is on the Clinical Decision Support page.
Payer codes and coverage describe what a provider recovers, not what either vendor charges, and neither publishes a price. Cleerly COMPARE is marketed without an identified clearance, and Heartflow's clearance numbers for Plaque Analysis, Roadmap and its May 2026 clearances are not on its pages.