Tuesday, September 15, 2026

Cardiac CT · Physiology · September 2026

CT-FFR in 2026: How the Vendors Compare

CFD vs deep learning vs plaque-integrated physiology: one CPT code, several different engines.

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)

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