Global Pathology Review — Path-iQ · Company Directory
The definitive guide to every major artificial intelligence pathology company — pure-play AI vendors, digital pathology platform providers, and scanner manufacturers with embedded AI. Includes FDA clearance status, funding, flagship products, and clinical deployment scale.
Section 1
Every company below has been independently reviewed by the Path-iQ editorial team. Data covers primary product lines, regulatory status, and publicly disclosed funding as of July 2026. Companies are ordered by year of founding.
The first AI pathology company to receive FDA De Novo clearance. Paige's algorithms detect cancer in whole-slide images; its enterprise platform integrates with major LIS vendors. Partners with Memorial Sloan Kettering Cancer Center.
PathAI focuses on AI-powered drug development and clinical trials. Its AISight platform enables biomarker quantification for pharma partners including AstraZeneca, Bristol Myers Squibb, and Pfizer. Spinout from Harvard.
Ibex's Galen platform detects and grades cancer in biopsy slides. Deployed in over 20 clinical labs across Europe and the US. Pioneered AI-assisted second-read workflows that run concurrently with the primary pathologist.
Proscia builds the Concentriq AP digital pathology platform — an enterprise-grade viewer and workflow system with embedded AI. Partners with Roche Diagnostics. Strong in academic medical centres and large hospital networks.
Indica Labs' HALO platform is the gold standard for research tissue image analysis. HALO AP is its clinical-grade IVD software. Widely used in pharma for biomarker quantification in oncology trials.
Pioneer in quantitative digital pathology. Visiopharm's APP marketplace offers 40+ pre-built algorithms for IHC quantification, tumour microenvironment analysis, and companion diagnostics.
Aiforia's cloud-based platform lets pathologists train, validate, and deploy custom deep-learning models without coding. Serves pharmaceutical companies and academic research labs across Europe and the US.
Tribun Health partners with French public hospitals (APHP) and operates one of the largest hospital-embedded AI pathology deployments in Europe. Its RoX platform handles primary read workflows at scale.
Sectra is a medical imaging company with a leading digital pathology module integrated into its enterprise PACS. Deployed in 30+ countries. Strong in Scandinavia, the UK (NHS), and North America.
Roche's digital pathology portfolio spans slide scanning (DP 200, DP 600), the NAVIFY cloud platform, and companion diagnostic IHC assays. One of the few integrated hardware-software-assay players in the market.
Leica Biosystems' Aperio scanner family is the most widely deployed WSI platform globally. The Aperio AI Suite integrates third-party algorithms; Leica also develops in-house AI for IHC scoring.
Hamamatsu NanoZoomer scanners are the scanner of choice for many leading research institutions and AI pathology companies — including Paige and PathAI, which trained models on NanoZoomer images.
Philips was an early mover in enterprise digital pathology. Its IntelliSite Pathology Suite combines ultra-fast scanning with a PACS-integrated viewer. Philips has been steadily expanding AI partnerships.
3DHistech is a major scanner manufacturer with a growing AI software ecosystem. Its Pannoramic scanners are popular in European research centres; Quant Center provides automated quantification.
Huron specialises in high-throughput whole-slide scanners for FFPE and frozen sections. TissueScope LE is designed for cost-effective high-volume clinical scanning, popular in Canadian academic hospitals.
SigTuple is India's leading AI pathology company. Its Manthana platform analyses peripheral blood smears, urine sediment, and sputum smears using AI. Deployed in 200+ labs across India. One of the few AI pathology companies with CDSCO approval.
Pramana develops AI algorithms for digital pathology with a focus on improving diagnostic accuracy in resource-limited settings. Backed by leading oncology research institutions.
Corista's DP3 platform is a vendor-neutral digital pathology viewer supporting multiple scanner formats. Strong in US academic medical centres; integrates with Epic and major EMR systems.
Moptim is a leading AI pathology company in China, with NMPA approval for cervical cytology AI and deployment across 500+ Chinese hospitals. Expanding into Southeast Asia and Europe.
OptraSCAN makes affordable whole-slide imaging scanners targeting emerging markets including India, the Middle East, and Southeast Asia. Partnering with Indian hospitals for AI-assisted telepathology deployments.
Section 2
FDA clearance is the gold standard for clinical AI pathology deployment in the United States. CE-IVD marks are required in the European Union; CDSCO approval is required in India. The table below covers all publicly known clearances as of July 2026.
| Company | Product | Indication | Pathway | Year | Region |
|---|---|---|---|---|---|
| Paige | Paige Prostate | Prostate cancer detection in core needle biopsies | De Novo | 2021 | USA |
| Paige | Paige Breast | Breast cancer detection in core needle biopsies | 510(k) | 2023 | USA |
| Paige | Paige Colorectal | Colorectal cancer detection | 510(k) | 2023 | USA |
| Ibex Medical Analytics | Galen Prostate | Prostate cancer detection & grading | 510(k) | 2022 | USA · EU |
| Ibex Medical Analytics | Galen Breast | Breast cancer detection | CE-IVD | 2022 | EU |
| Proscia | Concentriq AP | Digital pathology primary read viewer | 510(k) | 2021 | USA |
| Indica Labs | HALO AP | Digital pathology image analysis & reporting | 510(k) | 2020 | USA |
| Sectra | Sectra Digital Pathology | Whole-slide image viewing & management | 510(k) | 2019 | USA · EU |
| Leica Biosystems | Aperio GT 450 | Whole-slide scanning for clinical primary read | 510(k) | 2019 | USA · EU |
| Hamamatsu | NanoZoomer S360MD | Whole-slide scanning for primary diagnosis | 510(k) | 2020 | USA · EU · JP |
| Philips | IntelliSite Ultra Fast Scanner | Whole-slide scanning, primary diagnosis | 510(k) | 2017 | USA · EU |
| Roche / Ventana | NAVIFY Digital Pathology | WSI management, viewer, AI integration | 510(k) | 2021 | USA · EU |
| SigTuple | Manthana AI Platform | Peripheral blood smear, urine sediment, sputum | CDSCO · CE-IVD | 2019 | India · EU |
| Moptim | Moptim iPath (cervical) | Cervical cytology AI analysis | NMPA · CE-IVD | 2020 | China · EU |
Section 3
Pure-play AI pathology companies have attracted over $500 million in venture capital since 2016. Figures below are publicly disclosed rounds only.
| Company | HQ | Founded | Total Disclosed Funding | Last Round | Notable Investors |
|---|---|---|---|---|---|
| PathAI | Boston, USA | 2016 | $255 M | Series C, 2021 | General Atlantic, Tiger Global, AstraZeneca |
| Paige | New York, USA | 2017 | $95 M | Series C, 2022 | Memorial Sloan Kettering, MSD, Breyer Capital |
| Ibex Medical Analytics | Tel Aviv, Israel | 2016 | $55 M | Series C, 2022 | Insight Partners, Apax Digital, aMoon |
| Tribun Health | Paris, France | 2016 | €30 M | Series B, 2023 | Eurazeo, APHP, BPI France |
| Proscia | Philadelphia, USA | 2015 | $37 M | Series B, 2021 | Roche Ventures, Emerald Development Managers |
| Aiforia | Helsinki, Finland | 2013 | €15 M | Series B, 2021 | Tesi, Voima Ventures, Inventure |
| SigTuple | Bengaluru, India | 2015 | $19.5 M | Series B, 2020 | Accel, pi Ventures, Binny Bansal |
| Pramana | Boston, USA | 2020 | $10 M | Seed, 2022 | Undisclosed |
| Visiopharm | Hørsholm, Denmark | 2001 | Undisclosed | — | Bootstrapped / private |
| Indica Labs | Corrales, USA | 2012 | Undisclosed | — | Bootstrapped |
Section 4
The AI pathology company landscape divides into three distinct segments. Understanding these categories is essential when evaluating vendors for clinical deployment.
| Category | Description | Key Companies | Best For |
|---|---|---|---|
| Pure-Play AI Companies | Companies whose primary product is AI algorithms for pathology image analysis. They are scanner-agnostic and typically integrate via APIs into existing digital pathology platforms. | Paige · PathAI · Ibex Medical Analytics · Aiforia · Tribun Health · Pramana · SigTuple · Moptim | Labs that already have a scanner and platform and want to add AI triage or detection |
| Enterprise Digital Pathology Platforms | Companies that build the end-to-end infrastructure: LIS-integrated viewers, case management, reporting, and AI modules. Often scanner-agnostic or partnered with hardware vendors. | Proscia · Indica Labs · Visiopharm · Sectra · Corista · OptraSCAN | Hospitals implementing digital pathology from scratch; large academic medical centres |
| Scanner Vendors with AI | Hardware companies that make whole-slide imaging scanners and have added or integrated AI capabilities — either proprietary or through third-party partnerships. | Leica Biosystems · Hamamatsu · Philips · Roche/Ventana · 3DHistech · Huron Digital Pathology | Labs procuring new scanners who want an integrated hardware+software+AI solution from one vendor |
Section 5
India is an emerging market for AI pathology, driven by a shortage of pathologists (approximately 1 per 100,000 population vs. the WHO recommendation of 1 per 10,000), high cancer burden, and a rapidly growing network of accredited diagnostic laboratories.
| Company | HQ | India Presence | India-Specific Products | Regulatory |
|---|---|---|---|---|
| SigTuple | Bengaluru, India | Primary market — 200+ labs | AI100 smart microscope; Manthana for blood smears, urine, sputum | CDSCO approved · CE-IVD |
| OptraSCAN | Pune / Newark | Significant — multiple hospital deployments | OS-scan series designed for emerging market price points | FDA 510(k) · CE-IVD |
| Ibex Medical Analytics | Tel Aviv, Israel | Partnerships with Indian private labs | Galen Prostate (cancer detection) | FDA 510(k) · CE-IVD · CDSCO pending |
| Leica Biosystems (Aperio) | Germany / USA | Installed base in AIIMS, Tata, major hospitals | Aperio scanners; some AI integrations | FDA · CE-IVD |
| Hamamatsu | Japan | Growing — installed in premier research institutes | NanoZoomer series | FDA · CE-IVD · PMDA |
| Roche / Ventana / navify | Switzerland | Strong through Roche India diagnostics network | NAVIFY Digital Pathology; Ventana IHC assays | FDA · CE-IVD · CDSCO (assays) |
Section 6
Selecting an AI pathology vendor is a multi-year commitment. These are the criteria labs, hospitals, and health systems use when evaluating AI pathology companies.
| Criterion | What to Ask | Why It Matters |
|---|---|---|
| Regulatory clearance | Is the product FDA-cleared, CE-IVD marked, or CDSCO approved for your indication and jurisdiction? | Required for clinical use; also signals rigorous clinical validation |
| Clinical validation data | Has the algorithm been validated on data from your patient population, slide preparation method, and scanner model? | AI trained on US data may underperform on Indian or Asian populations; scanner mismatch degrades accuracy |
| Scanner compatibility | Which scanner brands and models does the AI support? | Switching scanners after AI deployment can require revalidation; lock-in is real |
| LIS / EMR integration | Does the platform integrate with your existing LIS (Cerner, Epic Beaker, SCC)? | Lack of integration forces double-entry and breaks workflow efficiency |
| Pricing model | Is it per-slide, per-case, annual subscription, or site licence? | Per-slide costs can be prohibitive at high volume; site licences benefit large labs |
| Support and training | Is there local support, onboarding, and CE/CME credit for pathologists? | Adoption rates correlate strongly with initial training quality |
| Data privacy and sovereignty | Where is slide data processed and stored? Is cloud processing compliant with local data laws (DPDP Act, HIPAA, GDPR)? | Critical for Indian government hospitals and EU institutions |
| Explainability | Does the AI provide heatmaps, confidence scores, or highlighted regions to support pathologist review? | Regulators and pathologists require interpretable outputs for trust and liability |
Section 7 — Frequently Asked Questions
Editorial and research-focused content only. Company data is sourced from public disclosures, press releases, and regulatory databases as of July 2026. Funding figures represent disclosed rounds only. Not investment advice. Not medical advice. Path-iQ is an independent editorial publication and has no commercial relationship with companies listed herein unless explicitly stated.