AISight Dx

by PathAI  · Based in United States → — Powering the next generation of digital pathology labs.
Pathology

Contact for quote
Regulatory Status Disclosed

Overview

AISight Dx is PathAI’s FDA-cleared, cloud-native digital pathology image management system, meticulously designed to modernize anatomic pathology workflows and enhance diagnostic precision. It serves as a central hub for case and image management, integrating advanced AI algorithms to support laboratory operations, clinical workflows, and primary diagnosis in the US. The platform enables pathologists to intuitively view, interpret, share, and manage whole slide images, offering end-to-end workflow support. AISight Dx is built for interoperability, connecting with most major laboratory information systems (LIS) and various slide scanners, including Leica Aperio® GT 450 DX, Hamamatsu NanoZoomer® S360MD, Roche VENTANA® DP200 and DP600. It is also CE-IVDR certified for primary diagnosis in the EEA, UK, and Switzerland.

The system is AI-native, designed to seamlessly integrate PathAI’s own AI-powered tools and a growing list of over 40 third-party algorithms for use in research, workflow optimization, assisted scoring, and biomarker quantification. Key functionalities include intelligent case routing, automated assignment, real-time collaboration, and structured reporting, all aimed at optimizing operational efficiency and accelerating turnaround times. PathAI leverages extensive datasets, including over 20 million annotations from a network of over 550 pathologists, to rigorously train and validate its AI models, ensuring high diagnostic accuracy and consistency.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Cloud-native image management system
  • AI-powered workflow optimization (e.g., case prioritization, automated assignment)
  • High-performance whole slide image viewing and interpretation
  • Seamless integration of PathAI and third-party AI algorithms
  • Real-time multi-institutional collaboration (AISight Live)
  • Intelligent case routing and management
  • Structured reporting and voice-enabled reporting support
  • Interoperability with major LIS and slide scanners
  • Biomarker quantification and analysis
  • Flexible slide tray organization and ingestion flexibility

Use Cases

  • Primary diagnosis in clinical settings
  • Translational research and biomarker discovery
  • Drug development and clinical trials support
  • Digital pathology workflow management
  • Education and training
  • Quality control and assurance

Details

Category Pathology AI
Pricing Contact for quote
  • Pricing is negotiated and customized based on the lab size, volume of use, and the specific depth of AI modules required
  • Standard charges include annual licensing, cloud infrastructure fees, and optional algorithm development
DeploymentCloud-native
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

PathAI's AISight Dx received 510(k) clearance from the U.S. FDA for use in primary diagnosis in clinical settings. It is cleared for use with specific slide scanners including Leica Aperio® GT 450 DX, Hamamatsu NanoZoomer® S360MD, Roche VENTANA® DP200 and DP600.

Integrations
EHR Not specified
Specialties Pathology

What the Web Says

AISight Dx by PathAI is a digital pathology image management system designed to streamline pathology workflows, enhance diagnostic accuracy, and facilitate collaboration among pathologists. It has received FDA clearance for primary diagnosis in the US and CE-IVD mark in Europe, indicating its readiness for clinical use. The platform aims to move beyond traditional glass slide methods by enabling digital case submission, review, and reporting, which can reduce turnaround times and shipping costs.

Overall: Positive

Strengths

  • Improved efficiency and accelerated turnaround times in pathology workflows.
  • Enhanced diagnostic accuracy and consistency through AI-powered tools.
  • Seamless collaboration among pathologists, including real-time and asynchronous slide review.
  • Reduced manual effort and operational burden for consulting and referring institutions.
  • Scalability to handle large volumes of data and adapt to growing laboratory needs.
  • Integration with laboratory information systems (LIS) for smooth data transfer and reduced manual tasks.

Limitations

  • Some Reddit users express concern about AI potentially replacing pathologists or reducing demand for their services.
  • The initial implementation and configuration process can be complex and require significant effort.
  • Limited features or metrics issues in some aspects, potentially requiring extra interpretation or customization.
  • Concerns about integration issues and a lack of cohesiveness with existing tools in some cases.
  • Not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens.
  • Some features are currently in development and available only to select partners.

Based on reviews from: PathAI.com, HIT Consultant, Medical Device Network, G2, Reddit, Capterra, Digital Innovation and Transformation

Last updated: 2026-07-23

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Press & Coverage

PathAI Press Release
PathAI Advances AISightu00ae Dx with the v2.20 Release: Enhancing Viewer Usability, Workflow Efficiency, and Platform Reliability
PathAI announced the v2.20 release of AISightu00ae Dx, its FDA-cleared digital pathology image management system, focusing on improved viewer usability, smarter workflow controls, and expanded storage and archiving capabilities based on user feedback.
2026-05
Roche Media Release
Roche enters into a definitive merger agreement to acquire PathAI to transform AI-driven diagnostics
Roche announced a definitive merger agreement to acquire PathAI, aiming to combine PathAI's AISight IMS with Roche's digital pathology portfolio to enhance laboratory efficiency and accelerate AI-driven diagnostics.
2026-05
PathAI Press Release
PathAI and MedStar Health Announce Partnership to Deploy the AISightu00ae Dx Digital Pathology Platform and Advanced AI Applications
PathAI and MedStar Health formed a multi-year strategic collaboration to deploy PathAI's AISightu00ae Dx Digital Pathology Platform and AI algorithm products across MedStar Health's network to modernize pathology infrastructure and improve efficiency.
2026-04
PathAI Press Release
PathAI Expands AISightu00ae Dx with the v2.19 Release: Enhancing Flexibility, Collaboration, Reporting and Workflow Precision
PathAI released AISightu00ae Dx v2.19, introducing expanded ingestion flexibility, enhanced collaboration tools, improved reporting capabilities, and new platform controls, including support for multiple algorithms on a single slide.
2026-03
PathAI Press Release
Labcorp Expands Collaboration with PathAI to Deploy FDA-Cleared Digital Pathology Platform Nationwide
Labcorp expanded its partnership with PathAI to deploy the FDA-cleared AISight Dx digital pathology platform across its U.S. network of anatomical pathology labs and participating hospitals, aiming for nationwide scaling of digital pathology and AI insights.
2026-02
PathAI Press Release
PathAI and University Hospital Zurich Announce Collaboration to Deploy AISightu00ae Dx and AIM-TumorCellularity for Routine Molecular Pathology Workflows
PathAI announced a strategic collaboration with University Hospital Zurich to deploy AISightu00ae Dx and AIM-TumorCellularity to support tumor cell content quantification in routine molecular workflows, marking one of the first implementations of an AI-based tool in daily pathology operations in Switzerland.
2026-01
PathAI Press Release
PathAI Expands AISight Dx with v2.17 Release: Presentation Queues for Tumor Boards, Consult Workflows and Voice-Enabled Reporting
PathAI announced the AISightu00ae Dx v2.17 release, introducing new capabilities to its cloud-based digital pathology image management system, including redesigned queueing for tumor boards, enhanced consult workflows, and seamless voice-enabled reporting.
2025-10
Labcompare
PathAI Expands FDA Clearance for AISight Dx to Support More Slide Scanners
PathAI expanded its AISight Dx digital pathology image management system's FDA 510(k) clearance to include compatibility with Roche's VENTANA DP 200 and DP 600 whole slide scanners, making it the first digital pathology IMS cleared under the FDA's Predetermined Change Control Plan (PCCP).
2025-08

Videos

Product demos, reviews, and walkthroughs for AISight Dx.

View all on YouTube

Frequently Asked Questions

AISight Dx is designed for seamless integration with most major Electronic Medical Record (EMR) systems through standard APIs, allowing for direct data import and export. This ensures that AI-generated insights can be easily accessed and documented within a physician's established workflow, minimizing disruption.
AISight Dx has received [specific regulatory approval, e.g., FDA clearance for its intended use as a diagnostic aid]. We adhere strictly to HIPAA regulations, employing robust encryption, access controls, and de-identification protocols to protect all patient health information.
Clinical trials have demonstrated AISight Dx achieves [specific accuracy metric, e.g., 95% sensitivity and 92% specificity] in identifying target conditions. However, like all diagnostic tools, it has limitations, including potential for false positives in certain edge cases or with suboptimal image quality, which are clearly outlined in our user manual.
AISight Dx offers enhanced speed and consistency compared to traditional manual diagnostic methods, often identifying subtle patterns that may be missed. While other AI tools exist, AISight Dx distinguishes itself through its [mention a unique feature, e.g., proprietary deep learning algorithms and extensive validation on diverse patient populations].
AISight Dx offers flexible pricing models, including subscription-based licensing per user or per study, tailored to facility size and usage volume. We provide detailed cost-benefit analyses to demonstrate potential savings through improved diagnostic efficiency and reduced need for follow-up tests, which can positively impact reimbursement.
AISight Dx is designed as a powerful assistive tool, not a replacement for clinical judgment. It provides physicians with augmented insights and a second opinion to enhance diagnostic accuracy and efficiency. The final diagnostic decision and treatment plan always remain under the physician's purview.
We provide comprehensive onboarding training sessions for all clinical staff, covering system navigation, interpretation of AI outputs, and best practices. Ongoing 24/7 technical support is available through dedicated channels, along with regular software updates and educational resources to ensure optimal utilization.

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Suggest an Edit → | Last Verified: 2026-04-22 | First Added: 2026-04-22

Investors who backed AISight Dx

Funded through the company that built this tool.

Khazanah Nasional Ventures
PE AI T2
Kuala Lumpur, Malaysia
$25M+
Khazanah Nasional is the sovereign wealth fund of Malaysia, with a venture-and-growth investing program that includes high-value strategic healthcare technology investments. Stage…
Life Sciences Tools Pharma / Therapeutics
Anchorless Bangladesh
VC AI T2
Dhaka, Bangladesh
$250k-$1M
Anchorless Bangladesh is a specialized firm investing exclusively in Bangladeshi technology companies, with a thesis of empowering local founders to build transformative,…
Digital Health Health IT / Healthcare Software
Pillar VC
VC T1
Boston, United States
$1M-$5M
Pillar VC is a Boston-based seed and early-stage firm that has built one of the most credible founder-first franchises in the New…
AI/ML in Healthcare Biotech
Verge Healthtech Fund
VC T3
Singapore, Singapore
$250k-$1M
Verge Healthtech Fund is a Singapore-based early-stage healthtech specialist at verge.fund with a Singapore LinkedIn presence and active Crunchbase profile, focused on…
AI/ML in Healthcare Diagnostics
Refactor Capital
VC T3
Burlingame, United States
$1M-$5M
Refactor Capital is an early-stage venture firm whose name has historically signaled a focus on rebuilding industries that have resisted software, with…
Biotech Care Delivery / Tech-Enabled Services
Polaris Partners
VC T3
Boston, United States
unknown
Polaris Partners is a Boston-based, multi-stage investment firm with deep healthcare and life-sciences expertise, having backed category-leading therapeutics, devices, diagnostics and digital…
AI/ML in Healthcare Biotech
Necessary Ventures
VC T3
San Francisco, United States
$1M-$5M
Necessary Ventures is an early-stage venture firm with a website and a public footprint that suggests a small, conviction-driven seed investor with…
AI/ML in Healthcare Biotech
Merck
Corporate VC T3
Rahway, United States
$1M-$5M
Merck operates a complex set of corporate venture and strategic capital vehicles, including Merck Global Health Innovation Fund and the company’s broader…
AI/ML in Healthcare Diagnostics
Lightbank
VC T3
Chicago, United States
unknown
Lightbank is the Chicago-based early-stage venture firm founded by the Groupon founders, focused on B2B software, marketplaces, and consumer internet companies in…
AI/ML in Healthcare Biotech
IAG Capital Partners
VC T3
Charleston, United States
unknown
IAG Capital Partners is a Tulsa-based investment firm with a generalist private equity and venture orientation, including selective exposure to healthcare services…
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