Pathology AI medical devices

A neutral, evidence-based catalogue of pathology AI medical devices. No manufacturer pricing, no buy links — just regulatory facts and clinical capability summaries.

Pathology

Paige Prostate Detect

Paige.AI (acquired by Tempus AI, August 2025)

CEFDAUKCA

Verified clinician reviews launching

Deep-learning software that analyses digitised whole slide images (WSI) of prostate needle core biopsies to detect foci suspicious for cancer and pinpoint — via a single X/Y coordinate — the site of highest malignancy probability for pathologist review. The algorithm operates as a second-read overlay within a digital pathology workflow; it does not render a standalone diagnosis.

Pathology

PathAI Platform

PathAI

CEFDA

Verified clinician reviews launching

End-to-end digital pathology platform combining an AI-powered image management system (AISight) with research-use AI algorithms for oncology, NASH and inflammatory disease.

Pathology

Galen Prostate / Galen Breast

Ibex Medical Analytics

CEFDA

Verified clinician reviews launching

AI for cancer detection and grading in digitised whole-slide images of needle-core biopsies. The Galen Prostate algorithm detects cancer, assigns Gleason grade, flags perineural invasion and estimates tumour size; sibling modules cover breast and gastric tissue and HER2 IHC scoring. In the US, the FDA-cleared product (Ibex Prostate Detect, formerly Galen Second Read) operates strictly as a parallel second-read alert tool; the broader First Read and non-prostate modules are CE-marked or research-use, not FDA-cleared.

Pathology

Paige Prostate Detect

Paige.AI

Editorial summaryPathology

ArteraAI Prostate

Artera Inc.

Sourced from FDA AI listPathology

INFINITT DPS

Infinitt Healthcare Co., Ltd.

Sourced from FDA AI listPathology

GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)

Geneseeq Technology Inc.

Sourced from FDA AI listPathology

“Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm”

Hologic Inc.

Sourced from FDA AI listPathology

xT CDx

Tempus Labs, Inc.

Sourced from FDA AI listPathology

Galen™ Second Read™

Ibex Medical Analytics Ltd.

Sourced from FDA AI listPathology

AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM

BD DIAGNOSTICS

Sourced from FDA AI listPathology

PAPNET Testing System

Neuromedical Systems, Inc.

Sourced from FDA AI list