Pathology

AI Prostate Cancer Prognosis From Pathology Images

Estimates how a prostate cancer is likely to behave from the biopsy slide image, to help decide how hard to treat it.

1 products cleared under FDA code SFH, from July 31, 2025 to July 31, 2025. Checked October 24, 2026.

Read the FDA name slowly, because it is a very different claim from anything else on this list: prognosis.

Detection software says this looks like cancer. Prognosis software says this prostate cancer looks like the kind that behaves badly, or the kind that does not.

That is the question patients and their doctors genuinely wrestle over. Prostate cancer is often slow, treatment has real costs, and many men are treated harder than their disease required because nobody could tell the difference in advance.

The FDA created a new device type for this, and its own definition says the result is meant to sit beside the other clinical facts, not to make the diagnosis. That is a strong signal that the regulator saw a different kind of claim rather than a better version of an old one.

Clearances per Year

What the FDA Actually Signed Off On

FDA product code
SFH
FDA name for it
Pathology Software Algorithm Device Analyzing Digital Images For Prostate 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 prostate cancer prognosis is a software intended to analyze digital images of acquired from medical imaging devices (for example but not limited to - whole slide imaging scanners). 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 what the prognosis output is used to decide, and ask your urologists and oncologists whether they would actually change treatment on it.
  • Ask which population the model was developed and validated in, and how close that is to yours.
  • Ask how the result is explained to a patient. This is the hardest conversation on this page and it happens in clinic, not in IT.

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 Prostate Artera, Inc. July 31, 2025 DEN240068

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.