US-based pathology solutions provider PathAI has received the US Food and Drug Administration (FDA) 510(k) clearance for its AISight Dx platform.
AISight Dx is a digital pathology image management system intended for use in primary diagnosis in clinical settings.
The cloud-native digital pathology platform aims to optimise anatomic pathology workflows.
It offers intelligent case management, high-performance slide review, and seamless live collaboration, reducing turnaround times and boost pathologist productivity for laboratories.
With features like integrated image management and robust annotation tools, the platform eliminates manual bottlenecks, supporting faster and more consistent diagnoses.
PathAI CEO Andy Beck said: “Digital pathology is the future of diagnostic medicine, empowering pathologists to work more efficiently and collaborate quickly without being limited to physical specimen review.
“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.”
The FDA approval builds on the initial 510(k) clearance for AISight Dx(Novo) in 2022, and includes a Predetermined Change Control Plan (PCCP).
PCPP allows PathAI to implement major changes such as new displays, scanners, and file formats without additional 510(k) submissions.
The regulatory alignment facilitates quicker software updates and hardware integrations, ensuring rapid innovation while maintaining FDA compliance.
Earlier this year, PathAI introduced PathAssist Derm, an AI tool operating on the AISight image management system.
The tool is designed to identify and measure skin lesions, supporting dermatopathology applications by automating tasks such as specimen orientation and lesion prioritisation.
PathAssist Derm can predict 17 different skin lesion entities, including both common and rare conditions.
The tool supports dermatopathology researchers by providing advanced characterisation of skin specimen entities, contributing to advancements in skin cancer research.
