HALO AP Dx

by Indica Labs  · Based in Mexico → — FDA-cleared case-centric pathology platform for primary diagnosis, remote working, and routine anatomic pathology workflows.
Pathology
Website
Claim this tool
Is this the maker? Claim the company →

Not specified publicly
Regulatory Status Disclosed

Overview

HALO AP Dx is an FDA-cleared enterprise digital pathology platform designed for primary diagnostic use in anatomic pathology laboratories. It facilitates a range of routine workflows, including primary diagnosis of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. The platform supports remote working, enabling pathologists to access and review whole slide images efficiently from various locations. Its browser-based interface streamlines collaboration, allowing for easy consultation with other pathologists, management of clinical trials, and participation in tumor boards. HALO AP Dx is cleared for use in conjunction with specific FDA-cleared slide scanners, such as the Hamamatsu NanoZoomer® S360MD and Leica Biosystems’ Aperio GT 450 DX Scanner, supporting both SVS and DICOM file formats. It provides a comprehensive suite of tools for efficient and accurate diagnostics, integrating patient data, digital slides, annotations, and reports into a single, ergonomic, case-centric environment.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • FDA-cleared for primary diagnosis
  • Case-centric pathology platform
  • Browser-based interface for accessibility
  • Supports remote working and diagnosis
  • Tools for consultations and second opinions
  • Clinical trial management module with blind scoring
  • Integration with FDA-cleared slide scanners (Hamamatsu NanoZoomeru00ae S360MD, Leica Aperio GT 450 DX)
  • Supports SVS and DICOM file formats
  • Secure URL sharing for collaboration
  • Enterprise-grade administration for scalability

Use Cases

  • Primary diagnosis of surgical pathology slides
  • Remote pathology workflows
  • Clinical trial management and blind scoring
  • Tumor board presentations
  • Pathologist consultations and second opinions
  • Research studies and system performance validation

What Physicians Need to Know

Whole Slide Image Support
Supports whole slide images (WSIs) from FDA-cleared scanners like Hamamatsu NanoZoomer S360MD and Leica Biosystems Aperio GT 450 DX. Compatible with DICOM, SVS, and OME.TIFF file formats, as well as over 20 other brightfield and fluorescent image formats.
Digital Pathology Integration
Browser-based image management solution designed for seamless integration into existing IT frameworks. Offers flexible on-premise or cloud-based deployments and integrates with PACS/VNA systems via a DICOM Transfer Module.
Stain Compatibility
Intended for use with Hematoxylin and Eosin (H&E) stained glass slides for primary diagnosis. Also compatible with a wide range of brightfield and fluorescent image file formats, and supports IHC quantification.
Biomarker Detection Capabilities
Leverages HALO Clinical AI for automated decision-support tools, including IHC quantification and identification/grading of cancer. Supports integration of third-party AI algorithms from the Aperio AI Store.
Turnaround Time Impact
Streamlines the diagnostic process, enabling faster diagnoses and reducing turnaround times by allowing remote review of scanned slides, eliminating the need for physical slide transfer.
CAP/CLIA Compliance
FDA-cleared for primary diagnostic use in the US (K232833, K252762) in conjunction with specific scanners. Provides built-in compliance with FDA 21 CFR Part 11 and HIPAA. HALO AP (the broader platform) is CE-IVDR marked for in-vitro diagnostic use in Europe, the UK, and Switzerland, and complies with GDPR. It is also being prepared for deployment as a laboratory developed test (LDT) in CAP/CLIA-certified laboratories.
Supported Cancer Types
FDA-cleared for primary diagnosis of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. AI applications (some for research use only) are available for prostate, breast (IHC), lung (PD-L1, NSCLC), colorectal, gastric, ovarian, and head and neck squamous cell carcinoma.
Quantitative Analysis Features
Unifies patient data, whole slide images, and AI-driven analytics into a single interface. Offers tools for quantitative analysis, including cell segmentation, spatial analysis, and IHC quantification, with results viewable in the browser.
LIS Integration
Works seamlessly with a broad range of Laboratory Information Systems (LIS/LIMS) via open, API-first technology for bi-directional connectivity. Expertise in integrating common LIS/LIMS systems, including Epic Beakeru00ae and Oracle Health EHR (formerly Cerner Millennium).
Physician Tip

Leverage HALO AP Dx for efficient remote primary diagnosis and streamlined collaboration on complex cases and tumor boards. Utilize its AI-powered quantitative analysis features for enhanced diagnostic precision and to prioritize urgent cases. Ensure adherence to the specified scanner compatibility and regulatory guidelines for diagnostic use. The platform's ability to integrate with existing LIS/LIMS systems minimizes disruption to current workflows while maximizing access to patient data and digital slides.

HALO AP Dx offers robust integration capabilities through open, API-first technology, supporting bi-directional communication with LIS/LIMS, PACS, and VNA systems. It is compatible with FDA-cleared scanners like Hamamatsu NanoZoomer S360MD and Leica Biosystems Aperio GT 450 DX, and supports various image file formats including DICOM and SVS. The platform also acts as an AI orchestration hub, allowing seamless deployment of both Indica Labs' HALO Clinical AI and third-party AI algorithms from the Aperio AI Store.

Details

Category Pathology AI
Pricing Not specified publicly — Not specified publicly
DeploymentOn-premise or cloud-based (AWS)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Yes AI-estimated

HALO AP Dx is FDA-cleared for primary diagnostic use with the Hamamatsu NanoZoomer® S360MD Slide scanner (K232833) and Leica Biosystems' Aperio GT 450 DX Scanner (K252762) in the USA.
Integrations
EHR Not specified
Specialties Pathology

What the Web Says

HALO AP Dx is an enterprise digital pathology platform by Indica Labs, designed for primary diagnosis of surgical pathology slides. It received FDA 510(k) clearance in May 2024 for use with specific Hamamatsu NanoZoomer scanners in the US, and holds CE-IVDR marking for in-vitro diagnostic use in Europe, the UK, and Switzerland. The platform aims to streamline diagnostic workflows, enable remote work and consultations, and integrate AI-driven analysis. It has been recognized in Best in KLASu00ae with high ratings for customer experience.

Overall: Positive

Strengths

  • Streamlines diagnostic workflows and reduces processing time.
  • Enables remote work and consultations, addressing pathologist shortages.
  • User-friendly interface enhances interpretation of complex morphological features.
  • Supports AI-driven analysis and integrates third-party AI algorithms.
  • Offers flexibility with cloud-based or on-premises deployment options.
  • Provides robust compliance with FDA 21 CFR Part 11, HIPAA, and GDPR.

Limitations

  • In the US, HALO AP Dx is currently cleared for use only with images acquired from the Hamamatsu NanoZoomer S360MD Slide scanner.
  • The HALO AP (non-Dx version) is for research use only in the US and not FDA cleared for clinical diagnostic use.
  • No specific negative reviews or opinions were found in the search results from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra.

Based on reviews from: Indica Labs (via vertexaisearch.cloud.google.com), Medical Device Network, accessdata.fda.gov, Facebook, GIIEvent, Molecular Pathology Laboratory Network, Inc.

Last updated: 2026-08-05

Ratings & Reviews

No reviews yet. Be the first to review this tool!

Rate HALO AP Dx

Clinical Value
Ease of Use
Integration
Support & Docs
Value for Money

Press & Coverage

PR Newswire
Indica Labs Receives FDA Clearance for HALO AP Dx Digital Pathology Platform for Use with Hamamatsu Images Acquired with the NanoZoomeru00ae S360MD Slide Scanner
Indica Labs announced FDA 510(k) clearance for its HALO AP Dx platform for primary diagnosis of surgical pathology slides, specifically for use with Hamamatsu NanoZoomeru00ae S360MD Slide scanner images. This clearance expands on an existing partnership between Indica Labs and Hamamatsu Photonics K.K.
2024-05
Indica Labs
Indica Labs Receives First FDA Clearance for HALO AP Dx Digital Pathology Platform
Indica Labs received its initial FDA 510(k) clearance for HALO AP Dx, an enterprise digital pathology platform for primary diagnosis, enabling its use with the Hamamatsu NanoZoomeru00ae S360MD Slide scanner for in-vitro diagnostic purposes. This marks a significant step for digital primary diagnosis in anatomic pathology labs in the US.
2024-05
Indica Labs
Indica Labs Receives FDA Clearance for Enterprise Digital Pathology Platform with Industry Leading DICOM-Compatible Aperio Scanner from Leica Biosystems
Indica Labs' HALO AP Dx platform received FDA 510(k) clearance for use with Leica Biosystems' Aperio GT 450 DX Scanner, supporting both SVS and DICOM file formats for primary diagnostics. This clearance signifies a major advancement in interoperability and functionality for digital pathology workflows.
2025-12
MLO Online
Indica Labs receives FDA clearance for HALO AP Dx digital pathology platform
Indica Labs announced FDA clearance for HALO AP Dx, an enterprise digital pathology platform for primary diagnosis, which can be deployed in cloud-based or on-premises environments and supports remote work and consultations. This clearance allows its use with the Hamamatsu NanoZoomer S360MD Slide scanner for in-vitro diagnostic use.
2024-05
Indica Labs
Introducing HALO AP Dx: An Enterprise Pathology Platform for Primary Diagnosis
This webinar introduces the FDA 510(k)-cleared HALO AP Dx platform, demonstrating its tools and workflows for efficient image evaluation, management, and collaboration in primary diagnostics. It covers common anatomic pathology workflows, including H&E and IHC image evaluation, and its utility for clinical trial management and tumor boards.
2024-06
Indica Labs
Lab Logic Brings Intelligent Case Orchestration to HALO APu00ae and HALO AP Dx
Indica Labs introduced Lab Logic for HALO AP and HALO AP Dx, a configuration layer that enables labs to tailor workflows, automate case triage, and route cases to appropriate experts. While HALO AP includes AI capabilities, these are not available in HALO AP Dx.
2026-06
Tissuepathology.com
Indica Labs: Diagnostic Digital Pathology Shaping the Future of Medicine
Indica Labs highlights how its HALO AP and FDA-cleared HALO AP Dx diagnostic digital pathology platforms are designed to integrate with existing IT infrastructure, offering pathologists a comprehensive toolkit for primary diagnosis, consultations, and clinical trials. The brochure explores features of both AI-powered HALO AP and FDA-cleared HALO AP Dx.
2026-01
Indica Labs
Looking Back: Reviewing 2025 at Indica Labs
Indica Labs reported a 200% year-over-year increase in clinical revenue from 2024-2025, driven by the adoption of HALO AP for clinical workflows and the expanded FDA 510(k) clearance of HALO AP Dx. The company also partnered with Leica Biosystems to launch Aperio HALO AP and the Aperio AI Store.
2025-12

Videos

Product demos, reviews, and walkthroughs for HALO AP Dx.

View all on YouTube

Frequently Asked Questions

HALO AP Dx is an FDA-cleared enterprise digital pathology platform designed for primary diagnosis of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It streamlines diagnostic processes by centralizing digital images and patient data, enabling remote work, and facilitating consultations and collaboration among pathologists.
HALO AP Dx is an AI-powered platform that integrates AI-based decision support tools, including Indica Labs' own HALO Clinical AI and third-party AI applications, to assist pathologists with analysis and quantification. However, it is intended as an aid to the pathologist, and a qualified pathologist remains responsible for making the final diagnostic decision.
HALO AP Dx is FDA-cleared for primary diagnostic use in the US with specific slide scanners, including the Hamamatsu NanoZoomer S360MD and Leica Biosystems' Aperio GT 450 DX. It also provides built-in compliance with FDA 21 CFR Part 11, ISO 13485:2016, and HIPAA, and is CE-IVDR marked for in-vitro diagnostic use in Europe, the UK, and Switzerland.
Yes, HALO AP Dx is specifically indicated for primary diagnosis of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens, and pathologists must still employ appropriate procedures and safeguards, including conventional light microscopy review when necessary.
While HALO AP Dx is a prominent solution, other digital pathology platforms and AI providers in the market include PathAI (with AISight Dx), Proscia (with Concentriq), Aiforia, DeepBio, Visiopharm, and Paige. These companies offer various features and AI capabilities for digital pathology workflows, often with different areas of specialization or integration models.
The pricing for HALO AP Dx is custom and varies based on several factors. These include the chosen deployment option (cloud-based or on-premises), the type of license (single-seat, multi-seat, or enterprise), and the license term (annual or permanent). Institutions are advised to contact Indica Labs directly for a tailored quote.
HALO AP Dx is designed for seamless integration with existing Laboratory Information Systems (LIS/LIMS), Picture Archiving and Communication Systems (PACS), and Vendor Neutral Archives (VNA). It utilizes open, API-first technology and standardized communication protocols to enable automated import, storage, and management of digital slide images and patient data without requiring replacement of current systems.

Related Tools

aisencia
aisencia GmbH
Clinical Decision Support & Reference
aisencia GmbH utilizes an AI system to detect and classify around 40 different skin disorders, supporting pathologists by reducing workload and speeding up diagnoses.
HistoGPT
AI Agent
Clinical Decision Support & Reference
HistoGPT is an AI tool that automates the generation of high-quality pathology reports from histology images, aiming to transform dermatopathology by enhancing diagnostic accuracy and efficiency.
Lumea Digital Pathology
Lumea
Clinical Decision Support & Reference
Lumea is a specialty-specific digital pathology platform that covers the entire diagnostic workflow, from biopsy to final report, and integrates AI tools from partners like Paige and Mindpeak.
Augmentiqs Augmented Reality Microscope (ARM)
Augmentiqs Medical Ltd.
Clinical Decision Support & Reference
Augmentiqs integrates augmented reality into existing microscopes, providing real-time access to digital pathology software, AI algorithms, and telepathology capabilities directly within the microscope's field of view.
Atlas by Gradient Health
Gradient Health
Developer Tools & APIs
Atlas by Gradient Health provides medical AI developers with instant access to large, diverse, and de-identified datasets for training and validating AI models at scale, offering multimodal data and a streamlined platform for data discovery and access.
Contact for pricing
Aperio iQC DX
Leica Biosystems
Lab & Diagnostics
The Aperio iQC DX software module, AI-powered quality control, is designed for the Aperio GT scanner series, and augments manual QC with fast, automated artifact detection of six most frequent quality issues. By identifying issues early, labs can reduce WSI review time, reallocate skilled staff to higher-value tasks, and improve overall lab efficiency.

See all Pathology AI tools →

Suggest an Edit → | Last Verified: 2026-05-06 | First Added: 2026-05-06
AI Tool Finder
AI-powered search. Results may not be comprehensive.