Who Is Behind AI Coronary Plaque Analysis?
AI-enabled quantitative coronary plaque analysis (AI-QCT) measures total plaque volume, non-calcified and low-attenuation plaque from a standard CCTA. The main US players are HeartFlow Plaque Analysis, Cleerly, Elucid PlaqueIQ (which adds histology-validated plaque morphology), and Caristo CaRi-Plaque. Newer FDA-cleared tools include Artrya Salix, Circle cvi42|Plaque and Keya Medical.
The field grew once Medicare set payment under Category I CPT 75577 (effective 2026). Caristo also goes beyond plaque. Its CaRi-Heart received FDA De Novo authorization in July 2026 for measuring coronary inflammation with the perivascular fat attenuation index (FAI), which is supported by ORFAN. Several vendors are also linking plaque results with CT-FFR into one report.
Key message: AI-QCT turns a CCTA into a measure of atherosclerotic burden, not just a stenosis grade. Plaque burden predicted MI better than stenosis in SCOT-HEART. However, outcome trials showing that plaque-guided therapy improves outcomes are still pending. Vendor numbers also cannot be used interchangeably, so serial scans should be analyzed with the same platform.
What it pays: in 2026, Medicare pays about $951 in the hospital outpatient setting (APC 1511) and about $1,012 in physician offices and imaging centers for CPT 75577. This is paid on top of the CCTA itself. Commercial coverage is growing: Aetna, Cigna, Humana and UnitedHealthcare have policies, but coverage typically requires stable chest pain and an intermediate CCTA result (CAD-RADS 1–3). For comparison, one well-known CT program charges self-pay patients around $850 for the analysis alone.
What vendors charge and what sites keep: none of the vendors publish their per-case fees. These are negotiated in contracts, so there is no verified public figure for hospital or practice profit. The margin is the Medicare payment minus the vendor fee, staff time and overhead. It depends heavily on contract terms, payer mix and denial rates. On-premise software (for example Circle cvi42) is marketed as keeping more of the payment in-house, while cloud services charge per case.
| CPT 75577 (2026) | Approx. payment |
|---|---|
| Medicare, hospital outpatient | ~$951 |
| Medicare, office / imaging center | ~$1,012 (national average) |
| Commercial insurance | Negotiated; varies by plan and criteria |
| Self-pay (analysis only) | ~$850 at one reported site; varies |
| Vendor fee / site margin | Not publicly disclosed |
| Company | Product | Distinctive feature |
|---|---|---|
| HeartFlow | Plaque Analysis | Built into the FFRct workflow |
| Cleerly | Cleerly Plaque / ISCHEMIA | Plaque staging plus AI ischemia estimate |
| Elucid | PlaqueIQ | Histology-validated tissue characterization |
| Caristo | CaRi-Plaque / CaRi-Heart | Plaque plus perivascular inflammation (FAI) |
| Artrya · Circle CVI · Keya | Salix · cvi42|Plaque · DeepVessel | Newer FDA-cleared options |
- SCOT-HEART: Low-Attenuation Plaque and MI (Circulation 2020)
- ORFAN: Coronary Inflammation and Cardiac Risk (Lancet 2024)
- Scientific Statements on AI Plaque Evaluation
- CPT 75577 and AI Plaque Reimbursement
- HeartFlow Next-Generation Plaque Analysis Clearance
- Elucid PlaqueIQ Reimbursement
- Caristo CaRi-Heart FDA De Novo (2026)
- Artrya Salix FDA Clearance
- Circle cvi42|Plaque FDA Clearance
- Medicare 2026 Payment for CPT 75577
- AI Plaque Reimbursement and Commercial Coverage (Circle CVI)
- Cleerly Coverage Criteria
- STAT: Medicare to Cover $1,000 AI Heart Scans
Status as of September 18, 2026, based on company and trade-press reports. Payment figures are national Medicare estimates before geographic adjustment and are not billing advice. For educational purposes only; not an endorsement of any product.
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