PathAI

PathAI's AISight Dx is a cloud-native digital pathology image management system that received FDA 510(k) clearance in June 2025 for primary diagnosis, building on an earlier 2022 clearance. The clearance included a Predetermined Change Control Plan, letting PathAI add scanners, displays, and file formats without fresh 510(k) submissions each time. In August 2025, Moffitt Cancer Center entered a multi-year collaboration to deploy AISight Dx across its pathology programs and co-develop AI diagnostics. The platform combines slide management, viewing, and collaboration with AI integration aimed at faster, more consistent diagnoses.

The practical constraint is the same as with any digital pathology platform: the AI is only as good as the digitization workflow feeding it, and labs need whole-slide scanners and storage infrastructure before the software delivers value. PathAI's algorithms remain assistive tools for pathologists rather than autonomous diagnosticians.

Labs deploy AISight Dx as a cloud-native platform integrated with their whole-slide scanners. Pathologists access slide review, case management, and collaboration tools through the web interface. Enterprise deployments include workflow configuration and biopharma research collaboration options.