AI Device Tracker / Pathology
FDA-authorised AI devices in pathology
10 AI-enabled devices with pathology as the lead FDA review panel, newest first. First in this list: 1995; most recent: 2026-05-04.
| Decision date | Device | Company | FDA record |
|---|---|---|---|
| 2026-05-04 | ArteraAI Breast | Artera, Inc. | K254115 · 510(k) |
| 2025-12-09 | INFINITT DPS | Infinitt Healthcare Co., Ltd. | K243449 · 510(k) |
| 2025-08-29 | GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) | Geneseeq Technology Inc. | K250003 · 510(k) |
| 2025-07-31 | ArteraAI Prostate | Artera Inc. | DEN240068 · De Novo |
| 2025-01-24 | Galen Second Read | Ibex Medical Analytics Ltd. | K241232 · 510(k) |
| 2024-01-31 | Genius Digital Diagnostics System with the Genius Cervical AI algorithm | Hologic Inc. | DEN210035 · De Novo |
| 2023-04-28 | xT CDx | Tempus Labs, Inc. | P210011 · PMA |
| 2021-09-21 | Paige Prostate | Paige.AI | DEN200080 · De Novo |
| 1995-11-08 | PAPNET Testing System | Neuromedical Systems, Inc. | P940029 · PMA |
| 1995-09-29 | AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM | BD DIAGNOSTICS | P950009 · PMA |
How to read this list
- 510(k) clearance means the FDA found the device substantially equivalent to one already on the market. Most AI devices reach the market this way.
- De Novo is used for new, low-to-moderate risk device types with no existing equivalent; it creates a new device category.
- PMA approval is the strictest route, for higher-risk devices.
- Authorisation means the device may be sold in the US for its stated use. It does not prove that the device improves patient outcomes, and it does not mean your hospital uses it.
- This list covers US FDA decisions only. Approval in the EU (CE marking) or the UK (UKCA) is a separate process.
Source: FDA Artificial Intelligence-Enabled Medical Devices list, downloaded 2026-11-05. Information only, not a recommendation of any device.