PathAI, a global leader in artificial intelligence and digital pathology solutions, 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. This latest milestone builds on the initial 510(k) clearance for AISight Dx(Novo) received in 2022 and underscores the platform's continuous innovation.
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.
Platform Capabilities and Design
AISight Dx is a cloud-native digital pathology platform designed to maximize efficiency in anatomic pathology workflows. The platform features intelligent case management, high-performance slide review, and seamless live collaboration capabilities that help labs accelerate turnaround times and optimize pathologist productivity.
With integrated image management, synchronized multi-slide navigation, and robust annotation tools, the platform eliminates manual bottlenecks and supports faster, more consistent diagnoses. The system is designed for interoperability, compliance, and scale, empowering anatomic pathology labs, hospital systems, and academic medical centers to modernize operations and deliver high-quality patient care.
Collaboration and Annotation Features
AISight Dx brings seamless, real-time collaboration to digital pathology, enabling synchronized and asynchronous slide review, expert consults, and education in a secure, user-centric workspace. With a share-ready image management system and flexible access from anywhere, the platform empowers specialists to connect and collaborate when and where it matters most.
The platform includes enhanced annotation features with a robust set of tools including lines, arrows, shapes, and freehand drawing, combined with threaded comments and user tagging to support asynchronous slide review. Users can tag colleagues in specific comments, which triggers immediate notifications and brings them directly to the relevant annotation, enabling fast and focused collaboration across teams.
Regulatory Status and Compatibility
AISight Dx is FDA-cleared 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. The platform offers seamless interoperability, supporting organizations of any size across multiple sites.
"Digital pathology is the future of diagnostic medicine, empowering pathologists to work more efficiently and collaborate quickly without being limited to physical specimen review," said Andy Beck, M.D., Ph.D., CEO of PathAI. "This 510(k) clearance showcases our commitment to quality and scientific rigor at PathAI and provides us a way forward to continually enhance our AISight Dx IMS."
