PathAI’s AISight Dx Wins FDA Clearance for Primary Diagnostic Use

PathAI has received FDA 510(k) clearance for its AISight Dx digital pathology image management system to be used in primary diagnosis. This expands on its initial 2022 approval and now includes use with Hamamatsu NanoZoomer S360MD and Leica Aperio GT 450 DX slide scanners.

1 July 2025

The clearance includes a Predetermined Change Control Plan (PCCP), enabling major software and hardware updates—such as new scanners, displays, and browsers—without further FDA review. AISight Dx is also CE IVD-marked for diagnostic use in the UK, EEA, and Switzerland.

The platform aims to streamline workflows through integrated slide management, annotation tools, and real-time collaboration features, boosting lab productivity and diagnostic speed. PathAI CEO Andy Beck called the clearance a step toward the future of diagnostic medicine and reaffirmed the company’s commitment to innovation and regulatory compliance.

01-07-2025