FDA-cleared AI pathology devices
The FDA's AI-enabled device list has 10 devices whose lead review panel is Pathology, 0.6% of all 1,614 listed devices. They come from 10 companies. The first decision was on September 29, 1995 and the most recent on May 4, 2026.
10AI devices
9Companies
1995First decision
2026-05-04Latest decision
Trend: devices per year
199520212023202420252026
Top companies
Most common product codes
All 10 devices, newest first
- ArteraAI BreastArtera, Inc. · Pathology
- INFINITT DPSInfinitt Healthcare Co., Ltd. · Pathology
- GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)Geneseeq Technology Inc. · Pathology
- ArteraAI ProstateArtera Inc. · Pathology
- Galen Second ReadIbex Medical Analytics Ltd. · Pathology
- Genius Digital Diagnostics System with the Genius Cervical AI algorithmHologic Inc. · Pathology
- xT CDxTempus Labs, Inc. · Pathology
- Paige ProstatePaige.AI · Pathology
- PAPNET Testing SystemNeuromedical Systems, Inc. · Pathology
- AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEMBD DIAGNOSTICS · Pathology
Frequently asked questions
How many FDA-cleared AI pathology devices are there?
As of the FDA list updated through June 29, 2026, 10 AI-enabled devices have Pathology as their lead review panel (0.6% of the list).
Which companies have the most AI pathology devices?
Artera, Inc. (1), Infinitt Healthcare Co., Ltd. (1), Geneseeq Technology Inc. (1) have the most AI-enabled pathology devices on the FDA list.
Which year had the most AI pathology authorizations?
2025 had the most, with 4 devices.
Which FDA pathways are used for AI pathology devices?
510(k): 4; De Novo: 3; PMA: 3.
What was the most recent AI pathology device on the list?
ArteraAI Breast from Artera, Inc. (K254115), with a decision dated May 4, 2026.