The expansion adds compatibility with Roche’s VENTANA DP 200 and DP 600 scanners and makes AISight Dx the first digital pathology image management system cleared under the FDA’s Predetermined Change Control Plan.
PathAI has expanded its AISight Dx digital pathology image management system’s US Food and Drug Administration (FDA) 510(k) clearance to support additional whole slide scanners through the agency’s Predetermined Change Control Plan (PCCP) framework.
The Boston-based AI and digital pathology company announced the expansion now includes compatibility with VENTANA DP 200 and DP 600 whole slide scanners, which received FDA clearance in 2024 as part of Roche Digital Pathology Dx medical device approvals.
With the label expansion, AISight Dx becomes the first digital pathology image management system to secure FDA clearance with an authorized PCCP. As of July 2025, fewer than 60 PCCP-authorized devices exist in the 510(k) database.
Leveraging PCCP for Efficient Expansion
The PCCP framework, part of FDA’s evolving approach to AI and machine learning-enabled devices, allows manufacturers to implement pre-specified modifications while maintaining regulatory compliance. PathAI leveraged this pathway to extend AISight Dx compatibility in what the company describes as a predictable, transparent and efficient manner.
The expansion was completed based on the PCCP approved as part of AISight Dx’s initial FDA clearance earlier this month under 510(k) number K243391. The original clearance included support for the VENTANA scanners cleared under K232879 and K242783.
“We’re thrilled to expand AISight Dx to support additional scanner platforms,” says Andy Beck, MD, PhD, co-founder and CEO of PathAI, in a release. “This milestone brings us closer to our mission of broadening access to more efficient digital pathology workflows, and over time, AI-powered diagnostics, ensuring pathologists have the flexibility and tools they need to deliver the best care for patients.”
Broader Scanner Support Strategy
The expansion demonstrates PathAI’s commitment to ensuring AISight Dx supports the broadest range of whole slide imaging scanners used across pathology laboratories. The company expects to announce further expansion of the AISight Dx label for primary diagnosis with additional slide image scanners and monitors in coming months.
AISight Dx is FDA-cleared for primary diagnosis in the US and is CE-IVD-marked for primary diagnosis in the European Economic Area, UK and Switzerland. The system serves as a digital pathology image management platform designed to support pathologists in diagnostic workflows.
The regulatory approach using PCCP could serve as a model for other digital pathology companies seeking to expand device compatibility efficiently while maintaining compliance with FDA requirements for AI and machine learning-enabled medical devices.
ID 385616547 © Iryna Kushnarova | Dreamstime.com
