PathAI Receives FDA Clearance for AISight® Dx Platform for Primary Diagnosis
BOSTON, June 30, 2025 (GLOBE NEWSWIRE) -- PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, today 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. Building on the initial 510(k) clearance for AISight Dx(Novo) in 2022, this latest milestone underscores the platform's continuous innovation and PathAI's commitment to delivering enhanced capabilities as the product evolves.
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.
AISight Dx is a cloud-native digital pathology platform designed to maximize efficiency in anatomic pathology workflows. From intelligent case management to high-performance slide review and seamless live collaboration, AISight Dx helps 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. Designed for interoperability, compliance, and scale, AISight Dx empowers anatomic pathology labs, hospital systems, and academic medical centers to modernize operations and deliver high-quality patient care with confidence.
'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.'
Learn more about AISight Dx here.
* AISight® Dx is FDA-cleared (K243391) 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.
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.
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