FDA-Cleared AI Device

HeartFlow FFRct Analysis

HeartFlow

Applies computational fluid dynamics to coronary CT angiography to estimate fractional flow reserve, a physiological measure normally obtained with an invasive pressure wire.

At A Glance

Manufacturer
HeartFlow
Medical specialty
Cardiology
Clearance route
FDA authorized
Year authorized
2014
Modality
Coronary CT angiography
Role in workflow
Clinical decision support

The clinical problem is that a coronary stenosis visible on imaging is not necessarily a stenosis that limits flow, and treating anatomy rather than physiology drives unnecessary catheterization. FFRct estimates the physiology from a scan the patient already had.

This is also the clearest example on this list of AI displacing a procedure rather than a perception task. The comparator is not a radiologist. It is a wire in an artery.

Where It Is Used

  • Assessment of hemodynamic significance in stable chest pain
  • Reducing invasive angiography in patients unlikely to benefit
  • Pre-procedural planning

Limitations Worth Knowing

Output quality depends heavily on the input scan: motion, calcium blooming, and inadequate contrast timing all degrade the model, and heavily calcified vessels remain the recognized weak case. Results near the treatment threshold deserve the same scepticism as any borderline invasive measurement.

Regulatory status, indications, and labeling change over time. Confirm current status on the FDA's AI/ML-Enabled Medical Devices list and in the manufacturer's current instructions for use before relying on anything stated here.

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