PathAI receives FDA clearance for AISight Dx platform for primary diagnosis
PathAI announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for AISight Dx*—its digital pathology image management system—for use in primary diagnosis in clinical settings.
The FDA decision also included a Predetermined Change Control Plan (PCCP), enabling PathAI to validate and implement specified major changes such as additional displays, scanners, file formats and browsers into AISight Dx without requiring additional 510(k) submissions. This proactive regulatory alignment accelerates future software updates and hardware integrations, allowing faster innovation while ensuring continued FDA compliance.
AISight Dx is a cloud-native digital pathology platform designed to maximize efficiency in anatomic pathology workflows. With integrated image management, synchronized multi-slide navigation, and robust annotation tools, the platform eliminates manual bottlenecks and supports faster, more consistent diagnoses. Designed for interoperability, compliance, and scale, AISight Dx empowers anatomic pathology labs, hospital systems, and academic medical centers to modernize operations and deliver high-quality patient care with confidence.
*AISight Dx is FDA-cleared (K243391) for primary diagnosis in the US with the Hamamatsu NanoZoomer S360MD and Leica Aperio GT 450 DX slide scanners, and is CE‑IVD–marked for primary diagnosis in the EEA, UK, and Switzerland.
