Episodios

  • September 2025 Digital Pathology Roundup

    September 2025 Digital Pathology Roundup
    Nov 1 2025
    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.
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  • August 2025 Digital Pathology Roundup

    August 2025 Digital Pathology Roundup
    Sep 30 2025
    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.
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    13 m
  • July 2025 Digital Pathology Roundup

    July 2025 Digital Pathology Roundup
    Aug 29 2025
    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.
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  • June 2025 Digital Pathology roundup

    June 2025 Digital Pathology roundup
    Jul 31 2025
    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.
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  • May 2025 Digital Pathology Roundup

    May 2025 Digital Pathology Roundup
    Jun 30 2025
    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.
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  • April 2025 Digital Pathology Roundup

    April 2025 Digital Pathology Roundup
    Jun 1 2025
    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.
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  • March 2025 Digital Pathology Roundup

    March 2025 Digital Pathology Roundup
    May 1 2025
    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.
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  • February 2025 Digital Pathology Roundup

    February 2025 Digital Pathology Roundup
    Mar 31 2025
    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.
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