CT-FFR in 2026: How the Vendors Compare
HeartFlow FFRct is still the reference standard. It was first cleared in 2014, uses off-site computational fluid dynamics checked by analysts, and has the most outcomes data (NXT, PRECISE). Two FDA-cleared competitors take a different approach. Keya DeepVessel FFR (cleared in 2022) builds a 3D coronary tree and estimates FFR with deep learning in minutes. Cleerly ISCHEMIA (K231335) predicts lesion-level ischemia from AI plaque and stenosis features rather than a flow simulation.
All three bill under Category I CPT 75580. The AI plaque analysis code (CPT 75577, effective 2026) is now pushing companies to offer anatomy, plaque and physiology together. Two more CT-FFR products are coming. Elucid BioIntegrated FFR-CT adds plaque morphology to fluid dynamics and is under 510(k) review. Artrya Salix Coronary Flow is being prepared for FDA submission, with clearance targeted for the second half of 2026.
Key message: the vendors differ in evidence depth, turnaround time and how FFR is derived, not in how they are billed. Scanner-based on-site CT-FFR tools have randomized data outside the US (TARGET) but are not widely available in US practice. Whichever engine you use, CCTA image quality still limits the result, and values in the 0.75–0.80 gray zone still call for clinical judgment.
| Vendor / product | Method | US status | Evidence base |
|---|---|---|---|
| HeartFlow FFRct | Off-site CFD, analyst-reviewed | Cleared 2014; CPT 75580 | Largest: NXT, PLATFORM, ADVANCE, PRECISE |
| Keya DeepVessel FFR | Deep learning, semi-automated, minutes | Cleared 2022; CPT 75580 | US/EU pivotal study; large China experience |
| Cleerly ISCHEMIA | AI plaque and stenosis model (no CFD) | Cleared (K231335); CPT 75580 | CREDENCE, PACIFIC validation |
| Elucid BioIntegrated FFR-CT | CFD plus plaque morphology | 510(k) pending | Multicenter trials ongoing |
| Artrya Salix Coronary Flow | AI-based, add-on to the Salix platform | Pre-submission; clearance targeted 2H 2026 | Validation completed (company-reported) |
- NXT Trial: diagnostic performance of FFRct (JACC 2014)
- PRECISE Randomized Trial (JAMA Cardiology 2023)
- TARGET Trial: on-site CT-FFR (Circulation)
- Keya DeepVessel FFR FDA Clearance
- Cleerly ISCHEMIA and CPT 75580
- HeartFlow: Category I Code for FFRct
- CCTA and AI Plaque Reimbursement (CPT 75577)
- Elucid BioIntegrated FFR-CT (Sept 2026)
- Artrya Salix Coronary Flow Update (July 2026)
Regulatory status as of September 15, 2026. Vendor claims come from company announcements. For educational purposes only; not an endorsement of any product.
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