Circle Cardiovascular Imaging vs Cleerly (2026)

AI Health Index verifiedSeptember 27, 2026
Verdict

Both quantify coronary plaque on CT, and they sit on opposite sides of the deployment question. Circle's cvi42 is software a hospital runs itself, on a workstation or customer managed server, with clinicians reviewing and editing the machine learning contours; it also reads cardiac MR and structural heart studies. Cleerly is a US based analysis service that adds an ischemia estimate validated in the prospective CREDENCE trial, and it publishes SOC 2 Type 2 and HITRUST reports for download. Circle's plaque clearance (K251027) reports agreement figures without case counts; Cleerly's ISCHEMIA clearance reports its figures with counts. If data must stay on site, or you read cardiac MR, start with Circle. If you want outsourced analysis with an ischemia estimate and prospective trial evidence, start with Cleerly.

The case for Circle Cardiovascular Imaging
  • Patient data must stay on site: cvi42 runs on a hospital workstation or customer managed server, and its models are locked and do not learn from customer data.
  • You read more than coronary CT: cvi42 covers cardiac MR, vascular CT, structural heart and electrophysiology planning.
  • Your readers want control of the contours: clinicians review and edit the machine learning segmentation, and version 6.5 made plaque segmentation editable.
The case for Cleerly
  • Ischemia is the question: Cleerly ISCHEMIA was validated in the prospective, multicenter CREDENCE trial against invasive FFR, and K231335 reports its figures with counts.
  • You want the security reports without asking: the trust center offers SOC 2 Type 2 and HITRUST reports for download.
  • Reimbursement is in place: Category I CPT codes cover plaque analysis and ISCHEMIA, and Cleerly publishes a payer policy lookup tool.

This comparison is published by AI Health Index, an independent research platform that compares healthcare AI vendors objectively. Circle Cardiovascular Imaging and Cleerly 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

At a Glance

Plain facts

Fact Circle Cardiovascular Imaging Cleerly
Primary category Radiology & Imaging AI Radiology & Imaging AI
Founded 2007 2017
Headquarters Calgary, Alberta, Canada Denver, Colorado, United States
Website circlecvi.com cleerlyhealth.com
Attribute Matrix

Side by Side

Select any grade to read the note behind it.

Axis
C
Circle Cardiovascular Imaging
C
Cleerly
AI Centrality
Autonomy and Oversight Model
Model and Technology Transparency
Model Supply Chain Disclosure
Clinical and Operational Evidence
AI Safety and PHI Stewardship
HIPAA and BAA Posture
Security Certifications and Trust Center
FDA and Regulatory Status
AI Governance and Bias Disclosure
AI Liability and Recourse
EHR and Interoperability Depth
Deployment Model and Data Residency
Commercial Transparency
Setting and Specialty Coverage
Change Log

Product updates

The latest logged changes from each vendor, newest first, each linked to its source.

Circle Cardiovascular Imaging

  • Product / capability

    Circle Cardiovascular Imaging released cvi42 v6.5, introducing automated phase offset correction, anti-aliasing, and pre-segmentation for 4D Flow.

    Source
All 1 Circle Cardiovascular Imaging update →
Citable Summaries

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.

Circle Cardiovascular Imaging

Circle Cardiovascular Imaging, based in Calgary and working in cardiovascular imaging since 2007, makes cvi42, vendor-neutral software for reading and reporting cardiac MR, cardiac and vascular CT, structural heart and electrophysiology planning, with StrokeSENS for acute stroke.

Source: AI Health Index, September 2026

Cleerly

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

FAQ

Questions buyers ask

How do Circle Cardiovascular Imaging and Cleerly work with the EHR?

Circle lists partner integrations on its site.

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. 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 Circle Cardiovascular Imaging and Cleerly priced and sold?

Circle publishes a coding and reimbursement guide and a reimbursement calculator, and describes Medicare payment for AI plaque analysis of CCTA (US$950 under Category III code 0625T, moving to a permanent Category I code from January 2026) and higher base payments for the CCTA exam.

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. 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 Circle Cardiovascular Imaging and Cleerly cover?

With Circle Cardiovascular Imaging, the plaque module's clearance limits it to adults' cardiac CT and its validation used US data only, and the company says not all modules are available in every region. Validation by setting for the other modules is not set out on the product pages.

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. 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 Circle Cardiovascular Imaging and Cleerly?

For Circle Cardiovascular Imaging, the cvi42 Coronary Plaque 510(k) summary (K251027) reports segmentation and plaque volume agreement with three expert annotators on held-out US data. The product page's headline, quantified risk and personalized care, cites category studies such as SCOT-HEART, CONFIRM, PARADIGM and SCCT consensus rather than any study of cvi42 Plaque.

With 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. 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.

Keep Comparing

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Disclosure

Circle's K251027 summary does not state the number of cases behind its agreement figures. Cleerly COMPARE is marketed without an identified clearance. Payer codes describe what a provider recovers, not what either vendor charges, and neither publishes a price.