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ProFound AI Risk

iCAD, now part of DeepHealth

Uses screening mammograms to estimate a woman’s near-term risk of developing breast cancer.

Designed for

Radiologist and breast care team

Care setting

Breast imaging center

Specialty

Breast imaging, Radiology

Public evidence assessedReviewed August 31, 2026

Bottom line

ProFound AI Risk has useful external validation showing that mammography-derived risk can be evaluated beyond its original development population. The unresolved question is clinical utility: whether its estimates are sufficiently calibrated to improve screening or prevention without inequitable overuse.

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 real image-based breast cancer risk product with published model evidence.

What remains uncertain

Prospective outcome benefit, calibration across populations, and effects of risk-guided screening pathways remain unresolved here.

How it was studied

ProFound AI Risk has been assessed in retrospective cohorts for its ability to estimate future breast cancer risk from mammography. A published external validation tested version 1.0 in a U.S. screening cohort that included White and Black women.

Intended use
Provide image-informed short-term breast cancer risk estimates to support personalized screening decisions where authorized.
Represented version
Public product materials accessed August 2026; software version not specified
Regulatory context
Official materials state that ProFound AI Risk is CE marked and Health Canada licensed, but not FDA cleared and investigational only in the United States.
For clinical and investment reviewEvidence context and questions for deeper review

Evidence source base

Published external validation and developer science materials. Calibration and clinical action policies remain site and version dependent.

Important limitation

Discrimination alone does not establish calibration, useful thresholds, benefit from changing screening, or equitable outcomes in the adopting population.

Questions to ask

  1. 01How is calibration maintained across populations and equipment?
  2. 02What action is recommended at each risk threshold?
  3. 03Does risk-guided screening improve patient outcomes?