Pathology

AI Breast Cancer Prognosis From Pathology Images

Estimates how a breast cancer is likely to behave from the slide image, to support treatment decisions.

1 products cleared under FDA code SHW, from May 4, 2026 to May 4, 2026. Checked September 25, 2026.

The breast cancer specific version of prognosis software, and the FDA gave it its own device type.

The decision it supports is one of the most common in oncology: who benefits from additional treatment after surgery, and who is being put through it for very little gain.

Existing ways of answering that question often involve sending tissue away for a genomic test, which costs a lot and takes time. Software that reads a slide you already have is a different economic proposition entirely.

Clearances per Year

What the FDA Actually Signed Off On

FDA product code
SHW
FDA name for it
Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis
Rule number
21 CFR 864.3755
Risk class
Class 2
Medical field
Pathology
The FDA's own wording: A pathology software algorithm device analyzing digital images for cancer prognosis is a software intended to analyze scanned whole slide images (WSIs) from breast cancer specimens prepared from formalin fixed paraffin-embedded (FFPE) tissue and stained using Hematoxylin & Eosin (H&E) stains. The device provides prognostic risk estimates which are intended to assist physicians with prognostic risk-based decisions along with other clinicopathological factors. The device is not intended to determine a clinical diagnosis.

Before You Sign Anything

  • Ask how it compares with the genomic test your team already trusts, on the same patients.
  • Ask what happens when the two disagree, and who decides.
  • Ask whether it was validated in the age groups and ethnic groups you treat, because breast cancer outcomes differ across them.

Every Cleared Product, Newest First

Each row links to the FDA's own record. The number in the last column is the clearance number, which is the single best thing to ask a vendor for.

ProductCompanyClearedFDA record
ArteraAI Breast Artera, Inc. May 4, 2026 K254115

Other Pathology Device Types

Clearance data comes from the FDA's public 510(k) and device classification records through openFDA. A clearance means the FDA agreed the product is close enough to something already on the market, not that the FDA tested it in your hospital. It says nothing about accuracy in your patient mix, your scanners, or your workflow. Confirm the current status and the exact cleared indication on the FDA record before you buy.