Summary:
PathAI has received FDA 510(k) clearance for its AISight Dx digital pathology platform, enabling its use in primary diagnosis and streamlining future updates through a Predetermined Change Control Plan.

Takeaways:

  • Regulatory Flexibility: The inclusion of a Predetermined Change Control Plan allows PathAI to implement major software and hardware updates without needing new FDA submissions.
  • Workflow Optimization: AISight Dx enhances pathology efficiency through cloud-native tools, intelligent case management, and real-time collaboration features.
  • Commitment to Innovation: This clearance reflects PathAI’s focus on advancing digital pathology with scalable, compliant solutions that improve diagnostic speed and consistency.

PathAI, a global provider of artificial intelligence (AI) and digital pathology solutions, 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.

PathAI Enabled to Validate and Implement Additional Changes

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 Maximizes Efficiency

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,” says Andy Beck, MD, PhD, 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.”

Featured Image: Pop Nukoonrat | Dreamstime.com

*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.