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      AISight Dx

      PathAI Receives FDA Clearance for AISightยฎ 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 AISightยฎ Dx*โ€”its digital pathology image management systemโ€”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 platformโ€™s continuous innovation and PathAIโ€™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.

      โ€œDigital pathology is the future of diagnostic medicine, empowering pathologists to work more efficiently and collaborate quickly without being limited to physical specimen review,โ€ said Andy Beck, M.D., Ph.D., CEO of PathAI. โ€œThis 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.โ€

      Learn more about AISight Dx here.

      *AISightยฎ Dx is FDA-cleared (K243391) for primary diagnosis in the US with the Hamamatsu NanoZoomerยฎ S360MD and Leica Aperioยฎ GT 450 DX slide scanners, and is CEโ€‘IVDโ€“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.

      Company Contact
      Liz Storti
      Chief People Officer
      elizabeth.storti@pathai.com

      Media Contact
      Owen Blaschak
      LifeSci Communications
      oblaschak@lifescicomms.com

       

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