Digital-Pathology-Today

The October 2025 digital pathology roundup with Imogen Fitt of Signify Research is here. Recent activity in digital pathology and AI spans new partnerships, implementations, and product launches.

Partnerships:
Alpenglow Biosciences & VirDx: Collaborating to create large-scale 3D light-sheet microscopy datasets as ground truth for VirDx’s MRI-based prostate cancer diagnostics, using NVIDIA accelerated computing to tightly link radiology and pathology.
Aiforia & Siemens Healthineers (Finland): After a broader European deal, Aiforia signed a local co-marketing/sales agreement with Siemens Healthineers’ Finnish affiliate to drive AI adoption in Finnish pathology as part of precision diagnostics.

Implementations:
Institut Curie: Entered a one-year agreement, funded by ARS Île-de-France, to use Aiforia’s CE-IVD clinical AI tools in routine pathology to support faster, more consistent diagnoses.
One Dorset Pathology (NHS): Signed a 7-year managed equipment service to deploy FUJIFILM SYNAPSE® Pathology on AWS, integrating partners like Sysmex, Menarini, Ibex, Barco, and Augnito. The goal is 100% digital reporting and meeting the UK 10-day histology target by early 2026.
Moffitt Cancer Center: Will implement four Pramana high-throughput scanners to support clinical and research work, including cytology and blood smears, with phased adoption through 2027.
Ouest Pathologie & Dedalus: Planning the largest French roll-out of the integrated Diamic-DeepUnity LIS + imaging platform across Bretagne/Normandie via a 7-year plan starting December 2025, enabling AI, tele-expertise, and unified image management.

Product launches & integrations:
Aignostics Atlas H&E-TME: Now generally available, offering rapid, single-cell-level TME readouts and >5,000 metrics per image from routine H&E, initially targeting biopharma research.
Proscia & Primaa: Integrated a skin AI module into Proscia’s platform for mitoses, hotspots, perineural invasion, and margin metrics in dermatopathology.
PathPresenter: Its vendor-agnostic clinical viewer achieved CE-IVDR marking for primary diagnosis in Europe, complementing its FDA 510(k) and enabling broader EU clinical deployments.

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.