PathAI, a global leader in artificial intelligence and digital pathology, has announced that its digital pathology image management system, AISight® Dx, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use in primary diagnosis in clinical settings. This clearance marks a major milestone in digital pathology innovation and builds on the company’s earlier 2022 clearance for AISight Dx (Novo).
This latest FDA decision includes a Predetermined Change Control Plan (PCCP), a forward-looking regulatory mechanism that allows PathAI to introduce major changes to AISight Dx—such as supporting new scanners, file formats, browsers, and display systems—without needing additional 510(k) submissions. This regulatory flexibility will significantly accelerate the platform’s future upgrades while maintaining compliance and safety standards.
AISight Dx is a cloud-native digital pathology platform designed to streamline and modernize workflows in anatomic pathology. The system integrates intelligent case management, high-performance slide review, multi-slide synchronization, and live collaboration tools to enhance diagnostic accuracy and efficiency. Its robust image management and annotation features eliminate manual delays and help pathologists achieve faster and more consistent diagnoses.
The platform is also built with scalability and interoperability in mind, making it suitable for large hospital systems, academic medical centers, and pathology labs. With compliance features embedded throughout, AISight Dx supports high standards in patient safety and diagnostic confidence.
Dr. Andy Beck, CEO and co-founder of PathAI, emphasized the significance of this clearance: “Digital pathology is transforming diagnostic medicine by allowing pathologists to collaborate remotely and work more efficiently. This FDA clearance validates the scientific rigor behind AISight Dx and gives us a pathway to continuously improve the platform.”
With this regulatory approval, PathAI is positioned to lead the ongoing digital transformation of pathology, helping labs adopt faster, more scalable diagnostic processes that ultimately benefit patient care.