Digital Pathology Roundup – September 2025

Funding:

Cyted Health raised €44m Series B led by EQT Life Sciences with Advent Life Sciences and British Business Bank; existing investors Morningside and BGF joined. Funds will drive US expansion, strengthen UK commercialization, and broaden tests beyond EndoSign, its minimally invasive oesophageal cell collection paired with advanced biomarker assays.

StratifAI closed €12.5m led by Picus Capital with Alven and others to clinically validate Polaris, a multimodal AI platform that fuses H&E histology, RNA-seq, and outcomes to generate prognostic and predictive spatial insights.

Regulatory Approvals:

Aiforia obtained CE-IVD for an AI tool detecting lymph node metastases, developed with University of Bern; the company claims up to 40% time savings in cancer staging.

Primaa secured CE-IVDR for Cleo Breast, automating biomarker detection on biopsy and surgical specimens and reporting ~15% faster diagnostics; approval enables wider EU deployment and FDA preparation.

Ibex earned CE-IVDR for HER2 IHC scoring within its Breast suite, developed with AstraZeneca and Daiichi Sankyo; the suite recognizes 54 breast tissue morphologies.

Partnerships and Product Moves:

Lunit partnered with Leica Biosystems to place its SCOPR PD-L1 tool in the Aperio AI Store; teamed with Agilent to co-develop AI-powered CDx solutions; and joined CellCarta to offer its pathology AI within CRO clinical trials workflows.

Proscia launched Aperture to turn routine diagnostic data into real-time insights for biomarker validation, CDx development, and submissions; it also enhanced Concentriq AP for cytology and partnered with Datexim to add cytology AI.

PathAI integrated Mindpeak’s 11 CE-IVD breast and lung tools (plus RUO assays), Stratipath’s CE-IVD prognostic breast model, and Primaa’s CE-IVDR breast and RUO dermpath tools into AISight Dx, further enlarging its CE-IVD ecosystem.

Here is the August Digital Pathology Roundup with Imogen Fitt of Signify Research.

1. Acquisitions:

Tempus AI is buying Paige for $81.25M, mostly in stock. Beyond headlines calling it a “data deal,” Tempus gains Paige’s ~7M de-identified whole-slide images plus seasoned AI/regulatory assets: Paige holds FDA Breakthrough Device Designations and De Novo clearances across prostate, lymph node, and PanCancer Detect. Tempus will also assume Paige’s existing Microsoft Azure cloud commitment.

Microscope maker Evident acquired AI-enabled scanner vendor Pramana—the first notable scanner-vendor acquisition in a while—prompting fresh questions about how hardware and AI stacks will consolidate.

2. Partnerships:

China’s Thorough Future announced a strategic partnership with Leica Biosystems to bring its multi-organ tumor-detection model (lung, stomach, prostate, intestine, lymph nodes) into Leica’s software; details remain light.

KFBIO struck a distribution deal with Malaysia’s CytoVision to bring KFBIO’s scanners, AI, and software to Singapore and Brunei. CytoVision, active since 2023 in digitization and education, already works with two Singaporean hospitals, positioning KFBIO for regional traction.

Techcyte extended its integration spree: (1) Modella AI’s PathChat co-pilot (and research-only PathChat DX, which has FDA Breakthrough status) to help pathologists summarize reports, interpret images, and query slides; and (2) DeepBio’s prostate and frozen-section algorithms. Initial DeepBio integrations will be RUO, with CE-IVD offerings in the portfolio and U.S. access planned via CLIA labs.

3. Regulatory:

ArteraAI secured FDA De Novo authorization for ArteraAI Prostate just 35 days after announcing Breakthrough Device status. It is now the first FDA-authorized AI tool to provide prognostic insights for patients with non-metastatic prostate cancer, and the decision creates a new product code that may streamline pathways for follow-on entrants.

Here is the July 2025 Digital Pathology Roundup with Imogen Fitt of Signify Research.

Partnerships:

Owkin launched a 5-year partnership with Newcastle Upon Tyne Hospitals NHS Foundation Trust to apply agentic AI across drug discovery, development, and diagnostics. First up: an AI tool to screen for gBRCA mutations in breast cancer, with Newcastle running validation studies and contributing multimodal data via Owkin’s ATLANTIS network (20 institutions across 7 countries, 11 therapeutic areas.

Lunit teamed with Microsoft to broaden access to cancer-detection AI through Azure-based model fine-tuning and agentic workflow tools; this follows Lunit’s growing DP footprint (e.g., SCOPE PD-L1 TPS integrating with Roche’s platform).

AIVIS and AstraZeneca Korea signed an MoU to build an AI-driven HER2 diagnosis ecosystem, clinically implementing AIVIS’ Qanti IHC under the newer, more granular HER2 classification.

Regulatory Milestones:

Artera received FDA Breakthrough Device Designation (BDD) for ArteraAI Prostate, the first AI risk-stratification tool in prostate cancer predicting metastasis risk and disease-specific mortality from WSIs.

CDx Diagnostics also earned BDD for WATS3D, which uses AI on 3D digital pathology images obtained via a proprietary brush for Barrett’s esophagus, dysplasia, and esophageal cancer—run in CDx’s CLIA/CAP/NYS-licensed lab.

Other 2025 BDDs include Paige (PanCancer Detect), Roche (VENTANA TROP2 RxDx), and Modella AI (gen-AI co-pilot). Reminder: BDD is not clearance; historically only ~10% progress to full FDA clearance.

AI Developments:

Google Research/DeepMind expanded MedGemma with MedGemma-27B Multimodal (including EHR interpretation) and MedSigLIP (lightweight image–text encoder) spanning radiology, dermatology, digital pathology, ophthalmology; MedGemma integrates FHIR and medical text. A joint study showed illumiSonics’ MLI can generate virtual H&E-like images from unstained skin tissue that Modella AI’s PathChat DX (without prior virtual-histology training) could analyze with high concordance versus eight dermatopathologists reviewing virtual and matched chemical H&Es—signaling growing momentum for stain-free imaging.

Funding:

Imagene raised a $23M Series B led by Larry Ellison and Oracle.

Scopio Labs unveiled its Complete Blood Morphology analyzer to automate peripheral smear review and analyze ~10× more cells than current practice; Viola Growth added $10M to Scopio’s Series D. Earlier in July, Scopio gained FDA clearance for a Decision Support System on X100/X100HT and a Peripheral Blood Smear app with AI-driven RBC morphology grading.

The June Digital Pathology Roundup with Imogen Fitt of Signify research is here.

Funding:

• RainPath AI raised €2.5M from Teampact.ventures, Xplore by Épopée Gestion, The Quest, Advance Lab, SHARPSTONE, about 15 angels, and Bpifrance. RainPath builds AI tools for virtual staining, smarter slide analysis, and structured reporting to cut reagent use and ease diagnostic bottlenecks. Funds will double headcount and advance product development and clinical validation.

• PreciseDx closed $11M led by Eventide, Merck GHI, and Philips Ventures, with Labcorp, Quest, GenHenn, and others. Eric Converse was named CEO and Ed Sitar CFO. Proceeds support more clinical data, commercial expansion, and prep for a 2026 launch of PreciseBreast, which provides phenotypic and grading insights to predict breast cancer recurrence risk.

Regulatory:

• PathPresenter received FDA 510(k) for its Clinical Viewer for primary diagnosis, cleared with Hamamatsu NanoZoomer S360MD NDPI images on a Barco NV MDPC8127 display. Broader device and file support is expected.

• PathAI secured FDA 510(k) for AISight Dx IMS for primary diagnosis with Hamamatsu S360MD and Leica Aperio GT 450 DX scanners; the IMS was first cleared in 2022 with the Philips Ultra-Fast Scanner. The FDA also approved a Predetermined Change Control Plan PCCP, allowing PathAI to add displays, scanners, file formats, and browsers without new 510(k) submissions, speeding platform expansion.

• Evident announced that SLIDEVIEW™ DX VS200 earned the CEIVDR mark in Europe. The scanner supports fluorescence, polarization, darkfield, and phase contrast, adding competitive choice in Western Europe.

Partnerships:

• PathPresenter and CAP unveiled an immersive AI platform for CAP members to trial tools from multiple vendors, launching at CAP25 Sept 13 to 16, Orlando.

• GI Alliance will adopt Lumea Viewer+ for its digital pathology entry, a significant deployment across 900 gastroenterologists and 400 plus sites.

• Leica extended its CDx collaboration with Bristol Myers Squibb. Parent Danaher formed another CDx partnership with AstraZeneca.

• Paige partnered with the Breast International Group to evaluate OmniScreen, focusing on novel biomarkers and real-world performance, especially in rare breast cancer subtypes. Paige also integrated with Roche Navify Digital Pathology.

Here is May's Digital Patholog Roundup with Imogen Fitt of Signify Research.

1. Digital Pathology as a Service (DPaaS): Histofy and Source BioScience announced a strategic partnership to enhance diagnostic workflows, starting with efficiency improvements and later expanding to deploy Histofy’s AI tools across Source’s UK-wide operations. Notably, Source BioScience is the UK’s largest histopathology provider and had previously acquired LD Path in 2022. This move reinforces the emerging trend of service-based digital pathology models, as seen with Inify Laboratories and PathologyWatch.

2. Platform Integrations: French AI company Bioptimus launched its H-optimus-1 model on AWS Marketplace, improving accessibility for life sciences. Meanwhile, Labcorp introduced an integrated digital pathology platform across its central labs, combining Leica Biosystems’ Aperio GT450 scanners with Proscia’s Concentriq LS system. The initiative aims to streamline scanning, archival, and companion diagnostic development for global clinical trials.

3. Artificial Intelligence: At Microsoft’s #Build2025, the company launched its Healthcare Multi-Agent Orchestrator, which includes Paige's Alba co-pilot for image-based pathology queries. Additionally, PictorLabs partnered with PathPresenter to integrate AI-based virtual staining into PathPresenter’s platform. Users can now apply virtual H&E, IHC, and special stains instantly on whole slide images for education, research, and clinical use—though FDA approval is still pending for PictorLabs’ solution.

4. Funding: Medmain Inc. raised $3.3 million to enhance its PidPort image management system, expand infrastructure, and pursue regulatory approval for its AI tools. This brings 2025’s total Digital Pathology VC funding to $168 million across 10 vendors, reflecting strong investor interest.

April’s Digital pathology Roundup with Imogen Fitt of Signify Research reflects strong momentum in digital pathology integrations, global AI expansion, and regulatory milestones.

Partnerships & Integrations: Visiopharm + Indica Labs: Visiopharm’s Discovery image analysis software is now integrated into Indica Labs’ HALO Link (v4.1) platform. This paid add-on allows seamless viewing of annotations, ROIs, and analysis summaries across platforms.

Paige + Burjeel Holdings: Paige’s AI solutions will be deployed across Burjeel’s 100 healthcare facilities in the MENA region (UAE, Saudi Arabia, Oman), expanding access to AI-powered pathology.

Paige + Sectra: Sectra will distribute Paige’s AI tools, enhancing Sectra’s digital offerings in radiology, cardiology, and pathology.

Mindpeak + DigitCells: Mindpeak’s AI algorithms will be integrated into DigitCells’ platform to enhance pathology automation.

Google Cloud + Endeavor Health: New cloud-based platform aims to accelerate diagnosis, facilitate second opinions, and enable direct patient-pathologist engagement by allowing patients to view images and consult with pathologists.

Regulatory Approvals: VIEWORKS: Korea’s VIEWORKS received CE IVDR certification for its VISQUE DPS LH510 scanner (supports tissue & cytology). The company plans European expansion. Roche: FDA granted Breakthrough Device Designation to Roche’s VENTANA® TROP2 CDx—first digital pathology companion diagnostic to receive this designation.

Funding: Gestalt Diagnostics: Raised $7.5M Series A (total $12M) led by Cowles Ventures and others. Funds will accelerate AI development, commercialization, and FDA approval efforts.

Leidos + Univ. of Pittsburgh: Leidos committed $10M over 5 years to fund the Computational Pathology Center, advancing research and clinical AI applications.

Clinical Pilots: Region Skåne (Sweden): Initiated proof-of-concept for Paige’s Prostate Suite. Success may drive broader regional adoption.

Listen to Digital Pathology Today on all major podcast platforms.

March saw major developments across digital pathology, including regulatory milestones, foundational AI models, strategic partnerships, and significant funding wins.

Regulatory Approvals:

Epredia earned FDA 510(k) clearance for its high-volume E1000 Dx Digital Pathology Solution, capable of digitizing up to 1,500 slides per day. Despite the hardware’s impressive capacity and features like dual slide processing and automated quality control, its immediate clinical appeal may be tempered by institutions’ preference for redundancy over sheer throughput. Still, Epredia’s longstanding customer trust and emphasis on quality may help drive early adoption. Meanwhile, PathAI received EMA qualification for its AIM-MASH AI tool, which standardizes biopsy scoring for MASH trials—well timed given the FDA’s recent approval of the first drug for the condition.

Foundation Models & Large Datasets:

Bioptimus launched ‘H-optimus-1,’ a massive pathology foundation model trained on over 1 million H&E slides from 800,000+ patients. It more than doubles the dataset used for their previous model and builds momentum following January’s major funding round. At HIMSS, HistAI debuted its SPIDER initiative, aiming to create a 50-million-image open-source dataset covering 20 organs. The first release includes 3 pretrained models targeting skin, colorectal, and lung—an ambitious step toward accelerating AI discovery and collaboration.

Partnerships:

Quest Diagnostics teamed up with Google Cloud to deploy generative AI for enhanced data analytics and customer experience. While not immediately diagnostic, such tools are paving the way for future clinical AI applications.

Funding:

Proscia raised $50 million in a round led by Insight Partners, boosting its total funding to $130 million. The funds will support platform adoption, AI enhancements, and deeper collaborations with Agilent and Siemens. The company also hinted at a future IPO—marking a promising trajectory for this digital pathology innovator.

February 2025 saw significant momentum in Digital Pathology, marked by strategic partnerships, platform expansions, and regulatory progress. Here is the February Round-up with Imogen Fitt of Signify Research.

Indica Labs partnered with Versant Diagnostics to deploy the HALO AP platform across U.S. labs, emphasizing usability, collaboration, and AI integration. Despite FDA approval for the NanoZoomer S360MD scanner, implementation remains complex due to diverse installed scanner bases. Deciphex extended its partnership with Charles River Laboratories, integrating its Patholytix platform to manage toxicologic pathology data. Building on its Foresight AI, Deciphex aims to enhance lesion and tissue coverage, strengthening its dominance in pharma toxicology.

In Digital Pathology–Genomics integration, Myriad Genetics and Lumea teamed up to streamline test ordering through Lumea’s platform, mirroring global trends toward centralized diagnostic systems. Additionally, Imagene and ArteraAI partnered with Tempus AI to distribute AI-powered assays, bypassing adoption barriers and potentially accessing Tempus' real-world datasets. These moves hint at deeper integration and potential acquisitions in the future.

AI portfolio expansion continued, with Paige’s PanCancer Detect growing to cover 40+ tissue types, fueled by Virchow V2 (trained on 3.1M slides). Paige also secured 510(k) clearance for more scanners and increased accessibility via key platforms, signaling renewed clinical focus.

Regulatory approvals were a highlight: Ibex Medical Analytics earned its first FDA 510(k) clearance for Prostate Detect, positioned as a safety net for pathologists. Meanwhile, Aiforia Technologies received IVDR certification in Europe, launching new CE-IVD models targeting breast and prostate cancer diagnostics.

Finally, Sectra announced a digital pathology pilot with William Osler Health System in Ontario, part of a decade-long enterprise imaging strategy. Integration with existing IT systems is increasingly seen as critical, as vendors aim for long-term growth through enterprise imaging tenders globally.

Here is January’s Digital Pathology round-up with Imogen Fitt of Signify Research.

FDA Clearances: Paige received FDA 510(k) clearance for its FullFocus™ digital pathology viewer to support additional scanners, the Leica Aperio GT 450 DX and the Hamamatsu NanoZoomer S360MD. Previously cleared for the Philips IntelliSite Pathology Solution, this approval expands Paige’s flexibility in the competitive U.S. market. Similarly, Roche’s VENTANA DP 600 slide scanner gained FDA clearance, boasting a 240-slide capacity, surpassing its predecessor and strengthening Roche’s commercial positioning in the U.S.

FDA Breakthrough Designations: Modella AI’s PathChat DX, a generative AI co-pilot for pathology, received FDA Breakthrough Device Designation. Developed at Mass General Brigham’s Mahmood Lab, PathChat DX builds on previously published research in Nature. However, this designation does not imply FDA clearance or guarantee future approval, with only 10% of such designations historically succeeding. The news underscores the growing role of generative AI in pathology while cautioning against premature assumptions about regulatory success.

Platform Integrations: HistoWiz integrated AI tools from Aiosyn and AIRA Matrix into its PathologyMap platform, targeting research markets where AI adoption is more widespread. Unlike the clinical sector, research environments have seen fewer AI partnerships, but this move signals a trend toward broader AI collaborations in pathology research.

Funding: Deciphex raised $32.3M in Series C funding, led by Molten Ventures and others, to support global expansion, platform development, and new AI models. The company also launched Diagnexia Analytix for drug development pathology. Meanwhile, Bioptimus secured $41M, bringing its total to $76M in under a year. Targeting biotech, medical, and cosmetic industries, Bioptimus plans to launch a new multi-scale, multi-modal foundation model in 2025. While AI advancements continue to generate excitement, commercial success depends on real-world clinical efficacy beyond just superior accuracy.

Imogen Fitt from Signify Research joins us for her predictions for Digital Pathology in 2025.

Trend 1 – Genomics and Digital Pathology Markets Becoming Inextricably Linked

Genomics and digital pathology are converging as distinct yet complementary fields. Increasingly, vendors are developing solutions that bridge the gap between these areas—for example, algorithms are being commercialized to extract genomic biomarkers directly from digital pathology images. Pharmaceutical companies are also collaborating with diagnostic and imaging firms, integrating multi-modal data from whole slide images to create digital companion diagnostics. Furthermore, strategic partnerships and investments (e.g., between molecular diagnostics firms and digital pathology vendors) are helping to merge the two fields. This integration not only enhances personalized medicine by providing a more comprehensive view of patient physiology but also improves laboratory workflows and pre-screening processes. Regions like Northern Europe have already started incorporating genomic data into digital pathology information management systems, demonstrating the growing market demand for such integration.

Trend 2 – Generative AI Boosting Lab Productivity

Generative AI (GenAI) is beginning to reshape lab operations by enhancing productivity and efficiency. Health tech and life sciences companies are actively exploring GenAI applications to automate report generation, consolidate knowledge, and streamline audit and quality control processes. Early initiatives from leading institutions like the Mayo Clinic and companies such as Sanofi illustrate the experimental use of GenAI in laboratory settings, particularly within digital pathology image analysis. Although the commercial impact of GenAI remains in its early stages, its potential to reduce manual tasks and enhance operational workflows is becoming increasingly recognized, indicating that GenAI will soon play a vital role in laboratory productivity improvements.

Trend 3 – Continued Consolidation in the Marketplace

The healthcare technology market is witnessing ongoing consolidation as vendors seek to strengthen their market positions by acquiring complementary businesses. This trend is driven by the need to expand capabilities and streamline product offerings, allowing companies to better meet the evolving demands of the industry. Such acquisitions enable vendors to combine expertise, reduce redundancies, and create more integrated solutions, thereby accelerating innovation and market penetration.

Trend 4 – Digital Pathology’s Clinical Growth Driven by Adjacent Stakeholders and Vendor Types

Although clinical adoption of digital pathology is still emerging, growth is being propelled by stakeholders from adjacent markets. BigTech companies—such as AWS, Microsoft, Google, and Dell—are entering the space, drawn by the revenue potential of whole slide image storage and real-world data management. Pharmaceutical firms are strategizing to secure reimbursement for digital companion diagnostics and exploring deployment models that integrate low-throughput pathology scanners in clinical settings. Additionally, radiology vendors are advocating for standardization efforts (like DICOM and Vendor Neutral Archives), which facilitate the integration of digital pathology systems with broader enterprise imaging platforms. New players in microscopy, laboratory information management systems (LIMS), teleradiology, and image exchange further underscore the expansive growth trajectory of digital pathology.

Overall, while challenges remain, these four trends illustrate a dynamic and transformative future for healthcare, promising significant advancements in patient care, research, and operational efficiency.