Latest news with #AISightDx
Yahoo
01-07-2025
- Business
- Yahoo
PathAI's digital pathology image management system gains FDA clearance
The US Food and Drug Administration (FDA) has granted 510(k) clearance to PathAI for its digital pathology image management system, AISight Dx, to be used in primary diagnosis in clinical settings. This clearance builds on the initial approval of AISight Dx (Novo) in 2022. AISight Dx has received FDA clearance (K243391) for diagnosis with the Hamamatsu NanoZoomer S360MD and Leica Aperio GT 450 DX slide scanners. It is also CE in vitro diagnostic (IVD)–marked for primary diagnosis in the UK, the European Economic Area (EEA), and Switzerland. The agency's latest decision included a Predetermined Change Control Plan (PCCP), which enables the company to implement major updates to AISight Dx such as scanners, new displays, file formats, as well as browsers, without the need for additional 510(k) submissions. This alignment paves the way for quicker software and hardware advancements while maintaining compliance with the agency's regulations. AISight Dx claims to aid laboratories in expediting response times and improving pathologist productivity. The system's integrated image management, synchronised multi-slide navigation, and annotation tools aim to eliminate manual processes and facilitate quicker diagnostic outcomes. AISight Dx enables anatomic pathology labs, academic medical centres, and hospital systems to update their operations and provide quality patient care. It is said to support real-time partnership, allowing both synchronised and asynchronous slide review, expert consultations, and educational opportunities in a user-focused environment. 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.' This February, the company introduced the PathAssist Derm AI tool, aimed at orienting, detecting, and measuring skin lesions. "PathAI's digital pathology image management system gains FDA clearance" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Associated Press
30-06-2025
- Business
- Associated Press
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 and follow us on LinkedIn. Company Contact Liz Storti Chief People Officer [email protected] Media Contact Owen Blaschak LifeSci Communications [email protected]
