Cleerly vs Heartflow
The two names that define cardiovascular CT AI win on different terrain. Heartflow created the non invasive coronary physiology category and holds the recognition no competitor matches: FFRCT is supported by the ACC AHA Chest Pain Guideline, a materially higher bar than a clearance, sitting on the largest evidence base in this index at more than 600 peer reviewed publications and clinical use across 400,000 plus patients. Cleerly's distinction is the payment machinery: its plaque quantification underpins Category I CPT codes, multiple Medicare contractor coverage determinations, and commercial policies reported to span more than 86 million covered lives. Two cautions belong in the verdict. Heartflow's Plaque and RoadMap functions are cleared only in the US and four other countries, with Europe, the UK, Australia, Canada, and Japan limited to FFRCT and Planner. And when Nature Reviews Cardiology benchmarked eight cleared plaque systems head to head, the publication records that Heartflow was unable to provide the required analysis for inclusion. If your failure mode is guideline backed physiology, start with Heartflow. If your failure mode is getting plaque quantification reimbursed, start with Cleerly.
- Reimbursement is the deciding constraint: the technology underpins Category I CPT codes, multiple Medicare Administrative Contractor coverage determinations, and commercial payer policies reported to span more than 86 million covered lives.
- Plaque phenotyping is the clinical question: comprehensive quantification and characterization of atherosclerotic disease from non invasive coronary CT angiography, with the multicenter international CONFIRM2 registry in the evidence base.
- Willingness to be compared: Cleerly appears among the eight cleared systems benchmarked head to head in the Nature Reviews Cardiology QCI consensus statement, the direct comparison Heartflow's analysis is absent from.
- Guideline recognition is the bar: FFRCT is supported by the ACC AHA Chest Pain Guideline, a higher bar than a 510(k) clearance and one no competitor in this lane holds.
- Evidence depth without rival: more than 600 peer reviewed publications, over 100 studies assessing more than 365,000 patients, and landmark work from SCOT HEART through the PRECISE trial to the DECIDE registry of roughly 22,000 patients.
- One platform across the pathway: RoadMap stenosis detection, FFRCT physiology, Plaque quantification, and Planner for intervention, four functions under Heartflow One in cleared markets.
Side-by-Side
| Axis | C Cleerly |
H Heartflow |
|---|---|---|
| AI Centrality | ||
| Autonomy and Oversight Model | ||
| Model and Technology Transparency | ||
| 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 | ||
| EHR and Interoperability Depth | ||
| Deployment Model and Data Residency | ||
| Commercial Transparency | ||
| Setting and Specialty Coverage |
Publication and patient counts are drawn from Heartflow's own evidence dossier and Cleerly's published materials; this index has not re verified the underlying studies. Regulatory scoping is critical and split: all four Heartflow functions are cleared in the US, Bahrain, Israel, Saudi Arabia, and the UAE, while Europe, the UK, Australia, Canada, and Japan are limited to FFRCT and Planner. Buyers should verify Cleerly's clearance status in their own market directly, as this record does not enumerate it. Neither vendor publishes pricing; the Category I CPT for automated plaque analysis, reported at US$950 per assessment from January 2026, is set by the payer system rather than either vendor.