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Cardiovascular imaging

Heartflow FFRCT Analysis

Heartflow

Uses coronary CT angiography to model coronary anatomy and estimate lesion-specific physiology noninvasively.

Designed for

Qualified clinician

Care setting

Hospital and cardiac imaging center

Specialty

Cardiology, Cardiac radiology

Public evidence assessedReviewed August 31, 2026

Our assessment

Bottom line

Heartflow FFRCT has a comparatively mature evidence base spanning diagnostic accuracy, regulatory review, and prospective pathway trials. The remaining questions are practical and longitudinal, including analyzability, turnaround, patient selection, equitable use, cost, and long-term outcome benefit.

Based on public sources. RIR did not independently test this product. This is not an endorsement or recommendation.

What the evidence supports

Reviewed sources establish a regulated, noninvasive coronary physiology analysis used alongside clinical history and other tests.

What remains uncertain

Current service performance, rejection patterns, subgroup effects, and incremental value in a specific local pathway require review.

How it was studied

Heartflow FFRCT has prospective diagnostic accuracy studies against invasive fractional flow reserve and later pathway trials. The NXT study supported authorization, while PRECISE prospectively randomized diagnostic strategies across 65 centers.

Product facts

Intended use
Support functional evaluation of coronary artery disease using previously acquired coronary CT angiography data.
Represented version
Heartflow FFRCT Analysis; current service version requires confirmation
Regulatory context
Heartflow publishes a defined intended use and warnings for its FFRCT Analysis. Current regional authorization and version should be confirmed.

Sources reviewed

4 public sources represented in this evidence profile.

Heartflow clinical evidence dossier including NXTEvaluation frameworkFDA 510(k) record for FFRctRegulatoryHeartflow FFRCT product overviewOfficial productHeartflow intended use and warningsOfficial documentation
For clinical and investment reviewEvidence context and questions for deeper review

Evidence source base

Peer-reviewed and regulatory evidence, much of it company sponsored. The exact service version and intended-use population must be matched to each study.

Important limitation

Diagnostic agreement and strategy trials do not ensure analyzability, turnaround, local selection, equitable use, or better long-term outcomes in every practice.

Questions to ask

  1. 01Which patients and CCTA acquisition protocols are eligible?
  2. 02How often are studies rejected or delayed?
  3. 03How does use change invasive testing and outcomes locally?
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