
PathAI
Digital pathology AI (AISight) for cancer diagnosis: FDA 510(k) and CE-IVD mark, $240M raised
Overview
PathAI is a digital pathology platform using AI to assist in or replace histopathology slide reading in oncology. Its flagship product, AISight Dx, covers breast, lung, and head-and-neck tumors with FDA 510(k) clearance (primary diagnosis US) and CE-IVD marking (primary diagnosis EU, UK, Switzerland). PathAI has raised roughly $240 million and ranks among the best-capitalized health AI startups. In 2023-2025, Quest Diagnostics acquired PathAI's CLIA lab and licensed the AISight platform, broadening access via one of the US's largest pathology networks.
PathAI does not officially offer a French-language interface. Pricing is entirely custom quotes based on lab size, annual slide volume, and required AI modules. Typical costs include annual license, cloud infrastructure (AWS/Azure), and specialized algorithms. An API enables integration to the lab's LIS. The main challenge for a small European structure is the need to digitize slides (expensive hardware, €100k-500k) before AI can engage. The absence of formalized local regulatory approval in Europe (CE-IVD applies EU-wide but does not ensure national clearance) may complicate deployment under strict regulatory frameworks.
Our verdict
Best for large pathology labs and academic hospital networks processing thousands of slides annually seeking to adopt digital pathology with recognized diagnostic AI. Not for you if you run a small lab: infrastructure (scanner, cloud, licenses) and expertise requirements make PathAI disproportionate investment.