Boston, MA – August 26, 2025 – PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, today announced the expansion of the AISight® Dx digital pathology image management system 510(k) label (K243391) to include the VENTANA® DP 200 and DP 600 whole slide scanners cleared in 2024 as part of the Roche Digital Pathology Dx medical device (K232879 and K242783). This expansion demonstrates PathAI’s ongoing commitment to ensuring AISight® Dx supports the broadest range of whole slide imaging scanners used across pathology laboratories.
The label expansion was completed based on the Predetermined Change Control Plan (PCCP) approved as part of the FDA clearance of AISight® Dx earlier this month. The PCCP framework, part of FDA’s evolving approach to AI/ML-enabled devices, allows manufacturers to implement pre-specified modifications while maintaining regulatory compliance. By leveraging this pathway, PathAI was able to extend AISight® Dx compatibility in a predictable, transparent, and efficient manner—ensuring both safety and performance are maintained as the device adapts to additional platforms. Notably, AISight® Dx is the first digital pathology image management system (IMS) to secure FDA clearance with an authorized PCCP—joining fewer than 60 PCCP-authorized devices in the entire 510(k) database as of July 2025.
“We’re thrilled to expand AISight® Dx to support additional scanner platforms,” said Andy Beck, MD, PhD, Co-Founder and CEO of PathAI. “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.”
PathAI expects to announce further expansion of the AISight Dx label for primary diagnosis with additional slide image scanners and monitors in the coming months.
Learn more about AISight® Dx here.
*AISight® Dx is FDA-cleared (K243391) for primary diagnosis in the US, and is CE‑IVD–marked for primary diagnosis in the EEA, UK, and Switzerland.
About PathAI
PathAI is a leading provider of AI-powered pathology solutions that aim to improve the accuracy of histology assessment and accelerate drug development. PathAI's platform leverages advanced artificial intelligence to analyze and interpret pathology images, providing valuable insights to pathologists, researchers, and pharmaceutical companies. PathAI is headquartered in Boston, MA. For more information, please visit www.pathai.com and follow us on LinkedIn.
