Sectra Digital Pathology Module

by Sectra  · Based in Sweden → — Pathology goes digital with an integrated AI-ready platform.
Oncology Pathology
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Regulatory Status Disclosed

Overview

The Sectra Digital Pathology Module is an FDA 510(k) cleared solution designed for primary diagnostics, enabling pathologists to utilize high-resolution digital images instead of traditional glass slides. This module integrates seamlessly with specific scanners, such as Leica’s Aperio GT 450 DX and AT2 DX scanners, and is a core component of Sectra’s comprehensive enterprise imaging platform (Sectra IDS7, UniView, VNA). It facilitates the adoption of AI in pathology practice through the Sectra Amplifier Service, offering tools and services to streamline workflows, enhance collaboration, and support medical education through digitized histopathology training. The solution is vendor-neutral, supporting various image formats and information systems for a full patient overview.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • FDA 510(k) cleared for primary diagnostics
  • Digital image review (replaces glass slides)
  • Integration with specific scanners (e.g., Leica Aperio GT 450 DX, AT2 DX)
  • Enterprise imaging platform integration (Sectra IDS7, UniView, VNA)
  • AI integration via Sectra Amplifier Service/Marketplace
  • Vendor-neutral solution with standardized interfaces (DICOM, HL7, XDS)
  • Workflow orchestration and management tools
  • Remote diagnostic capabilities with secure access
  • Integrated diagnostics and multidisciplinary collaboration (e.g., tumor boards)
  • Clinical training and medical education support (Sectra Education Portal)

Use Cases

  • Primary histopathology and cytology diagnostics
  • Digitized histopathology training and medical education
  • Integrated diagnostics across specialties (radiology, pathology, genomics)
  • Remote diagnostics and consultations
  • Multidisciplinary team (MDT) meetings / Tumor boards
  • Automated image analysis and AI-assisted workflows

What Physicians Need to Know

Whole Slide Image Support
FDA cleared for primary diagnosis with Leica's Aperio GT 450 DX (DICOM and svs) and AT2 DX scanners (svs). Supports DICOM and vendor-neutral whole-slide image formats, enabling high-speed display and intuitive interaction with large volumes of images, including remote access.
Digital Pathology Integration
Seamlessly integrates with specific scanners (e.g., Leica Aperio GT 450 DX, AT2 DX) and is a core component of Sectra's enterprise imaging platform (IDS7, UniView, VNA). It offers a vendor-neutral solution with standardized interfaces (DICOM, HL7, XDS) for integration with other image platforms, LIS, EMR, and macro cameras. Supports integrated diagnostics, allowing sharing of images and reports between radiology and pathology.
Stain Compatibility
FDA clearance specifies use with Hematoxylin and Eosin (H&E) stained glass slides for surgical pathology. The system also supports AI applications compatible with various stains, including ER, PR, HER2, Ki-67, PD-L1, and CMV immunohistochemistry, through its Amplifier Marketplace.
Biomarker Detection Capabilities
Features built-in image analysis and integrates with a broad portfolio of AI applications from partners (e.g., Ibex, Paige.AI, Mindpeak) for tasks such as automatic cell counting (e.g., Ki67), detection of tumor epithelium, scoring of ER/PR positive/negative cells, HER2 assessment, PD-L1 analysis, CMV detection, and identification of specific lesions and classifications across various cancer types.
Turnaround Time Impact
Significantly shortens report turnaround times and increases workflow efficiency by automating time-consuming tasks. This leads to faster delivery of diagnoses, reduced administrative burden, and improved pathologist efficiency (reported gains from 6% to 13%).
CAP/CLIA Compliance
FDA 510(k) cleared for primary diagnostics in the US, indicating compliance with regulatory standards for clinical use. Specific clearance details include use with Leica Aperio GT 450 DX and AT2 DX scanners and Dell MR2416/U3223QE monitors.
Supported Cancer Types
While FDA cleared for general surgical pathology, integrated AI applications support various cancer types including breast, prostate, non-small-cell lung carcinoma (NSCLC), colorectal, gastric, endometrial, melanoma, and skin biopsies, assisting in detection, grading, and biomarker profiling.
Quantitative Analysis Features
Includes built-in image analysis tools for measuring areas, distances, and annotations. Supports counting and percentage calculations, and integrates with AI applications for automated cell counting (e.g., Ki67), objective scoring of IHC biomarkers (ER, PR, HER2), and quantification of mitotic figures.
LIS Integration
Offers extensive integration capabilities with Laboratory Information Systems (LIS) and Electronic Medical Records (EMR) using standards like HL7. It can be integrated with specific LIS like Epic Beaker, ensuring a unified patient overview and efficient workflow orchestration by gathering metadata from integrated systems.
Physician Tip

Leverage the integrated diagnostics capabilities to correlate pathology findings with radiology and other imaging for a comprehensive patient view, especially in complex cancer cases and multidisciplinary team meetings. Utilize the remote access functionality for flexible work arrangements, consultations, and workload balancing, enhancing efficiency and collaboration across locations. Explore the Sectra Amplifier Marketplace for a wide range of AI-assisted tools to enhance quantitative analysis, biomarker detection, and streamline routine tasks like cell counting and case prioritization. Take advantage of the system's ability to handle large volumes and provide fast image display for quicker and more consistent reviews, contributing to reduced turnaround times. The vendor-neutral approach allows for flexibility in scanner choice and integration with various AI applications, ensuring access to best-of-breed tools.

The Sectra Digital Pathology Module is designed for extensive integration within an enterprise imaging strategy. It seamlessly connects with various high-volume pathology scanners, supporting both DICOM and proprietary file formats. Crucially, it integrates with Laboratory Information Systems (LIS) and Electronic Medical Records (EMR) using standards like HL7, ensuring a unified patient overview and streamlined workflows. The solution is a core component of Sectra's enterprise imaging platform (Sectra IDS7, UniView, VNA), enabling integrated diagnostics by combining pathology images with radiology, macro cameras, and genomic data. Furthermore, it offers a standard API and the Sectra Amplifier Marketplace for integrating a diverse portfolio of third-party AI and image analysis applications, fostering a vendor-neutral ecosystem for advanced histopathology tools.

Details

Category Pathology AI
Pricing Contact for pricing
DeploymentArray
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Sectra Digital Pathology Module is FDA 510(k) cleared for primary diagnostics, enabling the use of digital images rather than glass slides. In the USA, it is cleared for use with specific scanners like Leica's Aperio GT 450 DX and AT2 DX.
Integrations
EHR Not specified
Specialties Oncology, Pathology

What the Web Says

Sectra Digital Pathology Module is a highly-regarded solution among physicians and healthcare IT professionals, offering a comprehensive and vendor-neutral platform for digital pathology. It aims to improve diagnostic precision, efficiency, and collaboration in pathology workflows, particularly for complex cancer cases. The system has received FDA clearance for primary diagnostics in the US when used with specific Leica Biosystems scanners.

Overall: Positive

Strengths

  • Improved diagnostic precision and efficiency, especially for complex cases.
  • Enhanced collaboration among pathologists, radiologists, and other specialists, including remote consultations and multidisciplinary team meetings.
  • Better ergonomics for pathologists by reducing microscope use.
  • User-friendly interface and high system stability.
  • Supports integrated diagnostics across various medical imaging disciplines (radiology, cardiology, ophthalmology, etc.) on a unified platform.
  • Efficient workload balancing and management with intelligent worklists.

Limitations

  • Requires significant bandwidth for remote diagnostic reading, which can cause performance issues with poor internet access.
  • Some users have reported slow support response times due to staffing shortages.
  • Exporting large numbers of exams can be slow and may fail if the selection is too large.
  • Initial setup requires adapting existing procedures for specimen preparation to ensure high-quality digital images.
  • The cost structure for digitization will be different from traditional pathology, requiring preparedness for new expenses.
  • Concerns about potential future impact on in-house pathology services due to centralized digital reading.

Based on reviews from: Sectra Medical (Digital pathology brings only advantages at Gu00e4vle Hospital), Sectra Medical (Sectra Digital Pathology Solution), Sectra Medical (Pioneer shares experience of digital pathology), Sectra Medical (Healthcare region pioneering digital pathology reviews in Denmark with Sectrau2014aims to significantly shorten cancer turn-around times), Gitnux (Best Digital Pathology Software | 2026 Edition), MedTech Dive (FDA clears Sectra's digital pathology module for primary diagnostics as US market heats up), Sectra Medical (Sectra Digital Pathology Solution - Product Brief), Newswire.ca (MICHIGAN MEDICINE HARNESSES THE POWER OF SECTRA'S DIGITAL PATHOLOGY SOLUTION TO ENHANCE PATIENT CARE AND FOSTER COLLABORATION AMONG PHYSICIANS), Sectra Medical (The path to digital pathology: learning from Hospital for Special Surgery's journey), Sectra Medical (Is your health system ready for digital pathology?), Sectra Medical (Sectra Digital Pathology PACS), Sectra Medical (Digital pathology), Reddit (r/PACSAdmin - Any Sectra PACS users?), OPTA-TECH (Sectra Digital Pathology Solution), Reddit (r/Pathology - Anyone else wondering how digital pathology is changing training?), Sectra Medical (FDA clearanceu2014Sectra's digital pathology solution available for primary diagnostics and remote reading in the U.S.), KLAS Research (Sectra Digital Pathology 2022 | KLAS Spotlight Report), Reddit (r/PACSAdmin - AGFA or Sectra, which cloud PACS is the best you think?), Reddit (r/PACSAdmin - Choosing a new Radiology PACS...What do you love (and Hate)), Reddit (r/PACSAdmin - Sectra Ids7 - help exporting large amounts of data), Sectra Medical (100+ digital pathology implementations: 10 lessons learned, 1 essential conclusion)

Last updated: 2026-08-08

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Press & Coverage

MedTech Dive
FDA clears Sectra's digital pathology module for primary diagnostics as US market heats up
The FDA granted 510(k) clearance to Sectra's digital pathology module for primary diagnostics in the U.S., allowing the use of digital images instead of glass slides. This clearance intensifies competition in the U.S. digital pathology market.
2020-04
Clinical Lab Products
Sectra's Digital Pathology Module Receives FDA 510(k) Clearance
Sectra received FDA 510(k) clearance for its digital pathology module when used with Leica Biosystems' AT2 Dx scanner, enabling its use for primary diagnostics by US healthcare providers. This allows pathologists instant access to digital images and tools for review.
2020-04
PR Newswire
Three French healthcare providers digitize pathology with Sectra to enhance collaboration and cancer diagnostics
Three university hospitals in France signed contracts with Sectra to digitize their pathology workflows using Sectra's digital pathology module. This initiative aims to improve collaboration and cancer diagnostics by replacing microscopes with a digital workflow.
2025-08
Pharma Tech
Guelph General Hospital begins using Sectra's digital pathology module
Guelph General Hospital in Canada has implemented Sectra's digital pathology module to enhance diagnostic capabilities and workflow efficiency. The module is integrated into their existing Sectra One Cloud service, allowing pathologists instant access to digital images.
2025-05
Sectra (Press Release)
Guelph General Hospital First in Canada to Go-Live with Sectra's Digital Pathology Module
Guelph General Hospital in Canada has successfully activated Sectra's digital pathology module, becoming the first in the country to go live with the solution. This expands their existing Sectra One Cloud enterprise imaging platform to support modernized pathology workflows and integrated diagnostics.
2026-02
BioPharma BoardRoom
Sectra Enters Japanese Digital Pathology Market with First Implementation at Kameda Medical Center
Sectra has begun implementing its digital pathology module at Kameda Medical Center, marking its entry into the Japanese digital pathology market. This collaboration aims to advance diagnostic capabilities and support the country's healthcare needs with AI-enabled workflows.
2026-01
Sectra (Press Release)
Norwegian healthcare region expands solution from Sectra with digital pathology to improve cancer care
The South-Eastern Norway Regional Health Authority has expanded its contract with Sectra to include the digital pathology module, aiming to improve cancer care. This will enable pathology labs to share resources and expertise, ensuring high-quality diagnostics.
2023-04
Journal of Clinical and Translational Pathology
A Lifecycle Framework for Digital Pathology Implementation: Integrating Infrastructure, Workflow, Regulatory Compliance, and AI Readiness for Sustainable Adoption
This review article discusses a framework for implementing and sustaining digital pathology programs, including regulatory compliance. It mentions Sectra Digital Pathology Module 3.3 as an FDA 510(k) cleared viewer/IMS software for primary diagnosis.
2026-06

Videos

Product demos, reviews, and walkthroughs for Sectra Digital Pathology Module.

View all on YouTube

Frequently Asked Questions

The Sectra Digital Pathology Module is designed to integrate various image-based AI applications, supporting both certified clinical tools and research applications. These AI tools can enhance efficiency by assisting with tasks like automatic alignment of different stainings, cell counting (e.g., Ki67), and prioritizing cases with a high probability of relevant findings, thereby streamlining the pathologist's workflow.
In the US, the Sectra Digital Pathology Module is FDA cleared for primary diagnosis when used with specific Leica scanners and Dell monitors; however, this clearance does not currently include support for integrating image analysis. Ethical considerations for AI in digital pathology, such as patient privacy, data security, algorithmic transparency, and potential biases in training data, are crucial and require careful attention to ensure equitable and trustworthy diagnostic practices.
Physicians might face limitations such as the need for substantial IT infrastructure, including high bandwidth and storage capacity for large image files. Additionally, the FDA clearance for primary diagnosis does not extend to all specimen types, like frozen sections or cytology, and some complex cases may still necessitate traditional glass slide review. Challenges also include addressing potential algorithmic bias and ensuring data privacy when utilizing AI-driven tools.
While Sectra's platform is designed for vendor neutrality and integrates AI applications from various partners like Ibex Medical Analytics and Paige.AI, other enterprise imaging and digital pathology solutions exist. Competitors in the broader PACS/RIS market include vendors like Visage Imaging, Philips, and Intelerad, some of which also offer or integrate AI-powered tools for medical imaging.
Specific pricing details are not publicly disclosed, but the overall cost of implementing a digital pathology solution like Sectra's typically involves investments in data storage, PACS, scanners, client workstations (computers and monitors), and integrations with Laboratory Information Systems (LIS). Sectra also offers a software subscription model, Sectra One Cloud, which provides access to tools and features, and AI applications may be offered through services like the Sectra Amplifier Service, which can be fully managed and delivered via the cloud.

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Suggest an Edit → | Last Verified: 2026-05-06 | First Added: 2026-05-06
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