PathAI Granted FDA Clearance for AISight Dx for Primary Diagnosis in Clinical Settings

PathAI, a global leader in AI and digital pathology, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its AISight® Dx digital pathology image management system, allowing its use in primary diagnosis within clinical settings. This clearance builds on the platform’s initial 2022 clearance for AISight Dx(Novo), underscoring PathAI’s commitment to advancing innovation in digital diagnostics.

As part of the clearance, the FDA included a Predetermined Change Control Plan (PCCP), enabling PathAI to implement major updates—such as support for new displays, scanners, file formats, and browsers—without submitting additional 510(k) applications. This flexibility is expected to accelerate software updates and hardware integration, allowing faster innovation while maintaining regulatory compliance.

AISight Dx is a cloud-native platform designed to enhance efficiency in anatomic pathology workflows. It offers intelligent case management, high-performance slide review, and real-time collaboration tools to streamline operations, reduce turnaround times, and boost pathologist productivity. With features like integrated image management, synchronized multi-slide navigation, and powerful annotation tools, the platform eliminates manual bottlenecks and supports faster, more consistent diagnoses.

Built for interoperability, compliance, and scalability, AISight Dx empowers pathology labs, hospital systems, and academic medical centers to modernize their diagnostic processes and deliver high-quality care. “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.