Concentriq® AP-Dx is a comprehensive digital pathology solution designed to provide an intuitive experience for pathologists in viewing, interpreting, sharing, and managing whole slide images. It is specifically cleared by the United States (U.S.) Food and Drug Administration (FDA) for the purpose of primary diagnosis, making it suitable for clinical use. The platform is built to support clinical settings of all sizes, from individual reference laboratories to the largest hospital systems, helping to drive confidence and efficiency gains in diagnostic workflows. The solution facilitates real-time collaboration among colleagues, broadening access to expert opinions and fostering a more connected diagnostic environment. Its performant viewer and tools ensure an easy transition to digital pathology for labs, while robust interoperability features support large, multi-site organizations. While Concentriq AP-Dx is intended for diagnostic use, other components of the Concentriq platform, such as Concentriq AP and Proscia's AI applications, are designated for research use only. The platform is also cleared for primary diagnosis in the European Union (EU), Switzerland, and the UK, and is Health Canada licensed, demonstrating its global regulatory compliance.

Features & Benefits

• FDA-Cleared for Primary Diagnosis
  • Concentriq AP-Dx has received 510(k) clearance from the U.S. FDA for primary diagnostic use, ensuring regulatory compliance for clinical workflows.
• Comprehensive Whole Slide Image Management
  • Provides an intuitive experience for viewing, interpreting, sharing, and managing whole slide images, enhancing diagnostic confidence and efficiency.
• Scalability for All Clinical Settings
  • Designed to support clinical environments of all sizes, from individual reference laboratories to large hospital systems, ensuring adaptability and performance.
• Real-time Collaboration & Interoperability
  • Enables pathologists to collaborate with colleagues in real-time, broadening access to expertise and supporting seamless operations across multi-site organizations.
• Efficient Digital Transition
  • Offers a performant viewer and tools that facilitate an easy and smooth transition for laboratories adopting digital pathology workflows.
• Global Regulatory Compliance
  • Beyond U.S. FDA clearance, Concentriq Dx is cleared for primary diagnosis in the EU, Switzerland, and UK, and is Health Canada licensed.
• AI-Powered Diagnostics Integration
  • The platform is capable of delivering AI-powered diagnostics, as demonstrated in studies, to enhance operational efficiency and diagnostic throughput. (Note: Proscia's AI applications are available for research use only.)
• Specific Hardware Compatibility
  • Intended for diagnostic use only with the Hamamatsu NanoZoomer S360MD Slide scanner.