FDA-Cleared AI Directory
Pathology AI Cleared by the FDA
Software that reads digitized slides. Small in number, and the first products cleared to help predict how a cancer will behave.
Pathology is where the newest and most interesting clearances are, and it is still a short list.
Two things had to happen first. Labs had to scan glass slides into digital images at scale, and the FDA had to decide what such software was allowed to claim. Both are recent, which is why you will see clearance dates clustered in the last few years rather than spread across a decade.
Watch the prognosis products in particular. Detecting something in an image is a familiar job. Estimating how a cancer is likely to behave is a genuinely different claim, and the FDA created new device types to handle it.
Device Types in Pathology
The FDA sorts cleared AI into named device types. Each one has its own bar to clear, so the type tells you what the product is allowed to claim.
| Device type | What it is allowed to do | Cleared | Latest |
|---|---|---|---|
| Digital Pathology Assist Software | Helps a pathologist work through a digitized slide, by finding, counting or measuring what would otherwise be counted by eye. | 2 | January 24, 2025 |
| 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 | May 4, 2026 |
| AI Cancer Prognosis From Pathology Images | Estimates how a cancer is likely to behave from the slide image, to help decide how aggressively to treat. | 1 | July 31, 2025 |
| AI Cervical Cytology Slide Imaging | Scans cervical screening slides and uses AI to pick out the areas a human should review. | 1 | January 31, 2024 |
Newest Pathology Clearances
| Product | Company | Cleared | FDA record |
|---|---|---|---|
| ArteraAI Breast | Artera, Inc. | May 4, 2026 | K254115 |
| ArteraAI Prostate | Artera, Inc. | July 31, 2025 | DEN240068 |
| Galen Second Read | Ibex Medical Analytics , Ltd. | January 24, 2025 | K241232 |
| Genius Digital Diagnostics System with the Genius Cervical AI algorithm | Hologic, Inc. | January 31, 2024 | DEN210035 |
| Paige Prostate | Paige.Ai | September 21, 2021 | DEN200080 |
Clearance data comes from the FDA's public 510(k) and device classification records through openFDA. A clearance is a regulatory decision about a product, not a recommendation, and it does not measure how well the product works in your own setting. Confirm the current status and the exact cleared indication on the FDA record before you buy.