Concentriq AP-Dx
Contact for pricing
Regulatory Status Disclosed
Overview
Concentriq AP-Dx is an enterprise-grade digital pathology software solution designed to streamline the viewing, management, and interpretation of whole slide images (WSIs). It serves as a central platform to help clinical laboratories transition from traditional glass slide microscopy to a fully digital diagnostic workflow.
The software is built for pathologists and laboratory professionals working across various clinical settings, including individual reference laboratories, multi-site networks, and large hospital systems. It is intended for viewing and managing digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin-embedded (FFPE) tissue.
Concentriq AP-Dx integrates into the clinical workflow by bridging the gap between slide scanners, image storage, and Laboratory Information Systems (LIS). Pathologists can access cases, view high-resolution digital slides, and perform primary diagnoses from a single interface. Notable capabilities include:
- An intuitive, deep-zoom image viewer with annotation, cell counting, and measurement tools.
- Real-time collaboration features that facilitate remote consults, peer reviews, and tumor boards.
- A flexible integration engine supporting bidirectional LIS connectivity and multi-scanner interoperability.
- Configurable administrative controls to manage roles, permissions, and automated case assignments.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Comprehensive solution for primary diagnosis
- Intuitive viewing, interpreting, sharing, and managing whole slide images
- Scalable for individual reference labs to largest hospital systems
- Real-time collaboration with colleagues
- Performant viewer and tools
- Robust interoperability with scanners, LIS, and other software
- Integration of AI-powered diagnostics and biomarker detection
- Secure data management with encryption at rest and in transit
- Role-based access controls and audit logs
- Supports both SaaS (cloud) and on-premise deployment options
Use Cases
- Primary diagnosis in anatomic pathology
- Accelerating diagnostics and drug development
- Real-time collaboration and peer review
- Managing whole slide images across multi-site organizations
- Integrating AI for enhanced analysis and precision medicine
- Optimizing clinical trials and treatment decisions
What Physicians Need to Know
Evidence Base
Concentriq AP-Dx is FDA 510(k) cleared for primary diagnosis in the United States (with the Hamamatsu NanoZoomer S360MD slide scanner) and CE-marked under the EU IVDR for primary diagnosis. It is also licensed in Canada and cleared in the UK. The platform integrates AI applications for cancer detection, grading, and biomarker analysis, though Proscia's AI applications are available for research use only.
Clinical Validation Studies
A multi-site clinical study was conducted at PathGroup, South Bend Medical Foundation, and Spectrum Healthcare Partners to support 510(k) clearance. This study demonstrated that diagnoses made using Concentriq AP-Dx are non-inferior to traditional glass slide reads, with a -0.1% difference in major discordance rates, among the strongest findings in similar publicly available studies.
Alert Fatigue Management
While not explicitly termed 'alert fatigue management,' the platform features a pathologist-centric user experience designed for ease of use and efficiency, including a 'Focus Mode' to enhance concentration and configurable options to prevent multiple active tabs, aiming to reduce confusion.
Differential Diagnosis Support
The tool aids in primary diagnosis by providing a comprehensive environment for viewing, interpreting, and managing whole slide images. It integrates AI applications for cancer detection, grading, and biomarker analysis, and offers quantitative tools to support diagnostic decisions.
Guideline Update Frequency
Proscia regularly releases updates to the Concentriq platform, incorporating AI-native enhancements, expanded interoperability, and user experience improvements based on customer feedback.
Clinical Workflow Integration
Concentriq AP-Dx offers robust interoperability with LIS, scanners, and clinical systems, supporting digital case assembly, multi-site worklist management, and real-time collaboration. It integrates AI into routine pathology workflows for slide QC, image analysis, and quantitative scoring, including multi-AI workflows that display results from multiple applications simultaneously. The platform also features configurable worklists and case tagging.
Decision Audit Trail
The platform supports GLP studies with built-in audit logs and change-tracking for comprehensive traceability. Administrators have access to audit logs for visibility into data integrity, and users can download project audit logs for regulatory audits. Configurable roles and permissions help manage access and prevent inappropriate data deletion.
Physician Tip
To maximize the benefits of Concentriq AP-Dx, pathologists should leverage its FDA-cleared status for primary diagnosis and utilize the seamless collaboration features for efficient case review and expert consultations. Actively explore the integrated AI applications to enhance diagnostic analysis and improve efficiency. Customize worklists and workflows to align with individual preferences and optimize daily diagnostic tasks. Familiarize yourself with the audit trail capabilities for compliance and accountability.
Concentriq AP-Dx is designed as an open platform, ensuring broad interoperability with various LIS systems (including Epic Beaker, CoPath, NovoPath, LigoLab, and Orchard Harvest), major scanners, and third-party AI applications through its open API. It supports DICOM images, laying a foundation for IT efficiencies and enhanced interoperability. The platform can be deployed on-premise or via secure, HIPAA-compliant cloud infrastructure.
Details
| Category | Clinical Decision Support & Reference, Pathology AI |
| Pricing | Contact for pricing — N/A |
| Deployment | Cloud-based (SaaS), On-premise |
| Compliance | |
| BAA Available | Yes AI-estimated |
| HIPAA Compliant | Yes AI-estimated |
| FDA Status |
Yes AI-estimated Proscia has received 510(k) clearance from the United States (U.S.) Food and Drug Administration (FDA) for Concentriq AP-Dx (K230839) for the purpose of primary diagnosis, cleared for use with the Hamamatsu NanoZoomer® S360MD Slide scanner. It is also licensed in Canada and CE‑marked under the EU IVDR for primary diagnosis. |
| Integrations | |
| EHR | Not specified |
| Specialties | Pathology |
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Press & Coverage
CAP TODAY
Proscia gets new clearance for Concentriq AP-Dx - CAP TODAY
Proscia received a new FDA 510(k) clearance for its Concentriq AP-Dx digital pathology platform, which now includes compatibility with the Leica Aperio GT 450 DX slide scanner, cloud deployment, and a predetermined change control plan (PCCP). This PCCP allows Proscia to implement support for additional FDA-cleared scanners, image formats, and displays without requiring further 510(k) submissions.
2026-08
Lab Manager
Proscia Wins FDA Clearance to Expand Concentriq AP-Dx Interoperability | Lab Manager
Proscia's Concentriq AP-Dx digital pathology platform has received a new FDA 510(k) clearance, expanding its interoperability to include the Leica Aperio GT 450 DX slide scanner and cloud deployment. The clearance also features a Predetermined Change Control Plan (PCCP) to streamline future updates without requiring new 510(k) submissions for each addition.
2026-08
BioSpace
Proscia Receives New FDA 510(k) Clearance for Concentriq AP-Dx with Predetermined Change Control Plan - BioSpace
Proscia announced a new FDA 510(k) clearance for Concentriq AP-Dx, which now supports the Leica Aperio GT 450 DX slide scanner, cloud deployment, and incorporates a Predetermined Change Control Plan (PCCP). This regulatory milestone aims to provide a more efficient pathway for expanding the platform's interoperability.
2026-08
Dark Daily
FDA Clears Proscia Concentriq AP-Dx for Leica Aperio GT 450 DX Compatibility
The FDA has cleared Proscia's Concentriq AP-Dx digital pathology platform for compatibility with the Leica Aperio GT 450 DX slide scanner, cloud deployment, and a Predetermined Change Control Plan (PCCP). This clearance is expected to streamline future updates and expand the platform's interoperability for primary diagnosis.
2026-08
LabMedica International
FDA-Cleared Digital Pathology Platform Expands Interoperability for Primary Diagnosis
Proscia's Concentriq AP-Dx digital pathology platform has received a new FDA 510(k) clearance, enhancing its interoperability with the Leica Aperio GT 450 DX slide scanner and enabling cloud deployment. The clearance also includes a Predetermined Change Control Plan (PCCP) to facilitate future updates and maintain regulatory oversight.
2026-08
Imaging Technology News
Proscia Introduces Fifth Generation of Concentriq - Imaging Technology News
Proscia has launched the Fifth Generation of its Concentriq platform, which introduces intelligence to support pathologists and scientists in drug discovery, development, and case review. Concentriq AP-Dx, a configuration of this platform, is FDA-cleared for primary diagnosis with the Hamamatsu NanoZoomer S360MD Slide scanner.
2026-06
Proscia (Press Release)
Proscia Launches Fifth Generation of Concentriq, Bringing the Latest Advancements in AI to Pathologists and Scientists
Proscia unveiled the Fifth Generation of its Concentriq platform, designed with an AI-native architecture to provide clinically and scientifically grounded intelligence. Concentriq AP-Dx, part of this portfolio, is FDA-cleared for primary diagnosis in the U.S. with the Hamamatsu NanoZoomer S360MD Slide scanner.
2026-06
PubMed Central (NIH)
Deep Learning Image Processing Models in Dermatopathology - PMC - NIH
This peer-reviewed article discusses deep learning models in dermatopathology, noting that Proscia's DermAI model is integrated with the Concentriq AP-Dx platform. Concentriq AP-Dx received FDA 510(k) clearance in February 2024 for primary diagnosis in U.S. clinical settings when used with the Hamamatsu NanoZoomer S360MD Slide scanner.
2025-10
Videos
Product demos, reviews, and walkthroughs for Concentriq AP-Dx.
FDA Cleared Digital Pathology Software | Concentriq APDx by Proscia
Dr. Aleks Digital Pathology & AI
Frequently Asked Questions
Concentriq AP-Dx is a comprehensive digital pathology software solution designed to help pathologists view, interpret, share, and manage whole slide images for primary diagnosis. While the platform itself is FDA-cleared for primary diagnosis, Proscia's specific AI applications integrated within the Concentriq platform are generally for research use only and not for diagnostic procedures. The platform does, however, lay the foundation for computational pathology and can integrate AI for tasks like slide QC and image analysis within research workflows.
Concentriq AP-Dx has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for primary diagnosis when used with the Hamamatsu NanoZoomer S360MD Slide scanner. It also holds CE-IVDR certification for primary diagnosis in the European Union and is licensed in Canada. The platform is designed to support robust security and compliance, including features to help meet HIPAA requirements through configurable roles, permissions, and data encryption.
Concentriq AP-Dx is specifically cleared for primary diagnosis with certain whole slide images, but it is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens. Pathologists should be aware of these limitations when integrating the system into their diagnostic practices.
Several other digital pathology platforms offer similar functionalities for managing and reviewing whole slide images. Notable alternatives include Philips IntelliSite Pathology Solution, Aperio by Leica Biosystems, CaseManager DX by 3DHISTECH, and the Paige Platform. These systems also aim to digitize anatomic pathology workflows and often include features for image management, collaboration, and LIS integration.
Specific pricing details for Concentriq AP-Dx are not publicly disclosed, as pricing is generally based on the duration and terms of the contract negotiated directly with the vendor, Proscia. Institutions should anticipate that additional AWS infrastructure costs may apply if the solution is deployed on Amazon Web Services. It's advisable to engage directly with Proscia for a detailed quote tailored to your institution's specific needs and scale.
Concentriq AP-Dx is designed to streamline collaboration by enabling pathologists to easily share, interpret, and manage whole slide images across different locations. Its browser-based nature allows for remote access and real-time collaboration with colleagues, broadening access to expertise. The platform supports configurable roles and permissions, which is crucial for managing access and workflows in large, multi-site hospital systems or reference laboratories.
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| Last Verified: 2026-05-13 | First Added: 2026-05-13
Investors who backed Concentriq AP-Dx
Funded through the company that built this tool.
SoGal Ventures
VC
T3
Care Delivery / Tech-Enabled Services
Diagnostics
Scale Venture Partners
VC
T3
AI/ML in Healthcare
Care Delivery / Tech-Enabled Services
Hitachi Ventures
Corporate VC
T3
AI/ML in Healthcare
Biotech
Fusion Fund
VC
T3
AI/ML in Healthcare
Biotech
Flybridge
VC
T3
AI/ML in Healthcare
Digital Health