Imogen Fitt, a digital pathology industry expert and insightful commentator, shares the latest updates in the field. She discusses Cyted Health's €44M funding for US expansion and StratifAI's AI platform advancements. Imogen highlights key regulatory approvals, including Aiforia's CE-IVD tool for lymph node detection and Primaa’s Cleo Breast for faster diagnostics. They also explore Lunit's strategic partnerships and Proscia's launch of Aperture for real-time biomarker insights, along with trends from recent conferences.
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insights INSIGHT
Multimodal Platforms Attract Significant Funding
Cyted Health raised €44m to expand US operations and broaden tests beyond a minimally invasive esophageal cell collection.
StratifAI secured €12.5m to clinically validate Polaris, a multimodal AI platform fusing H&E and RNA-seq for spatial prognostic insights.
insights INSIGHT
AI Cuts Lymph Node Review Time
Aiforia gained CE‑IVD for a lymph node metastasis detector developed with University of Bern, claiming up to 40% time savings.
The tool targets micrometastases detection—a routine but time-consuming pathology task.
insights INSIGHT
CE‑IVDR Enables Faster Breast Biomarker Workflows
Primaa achieved CE‑IVDR for Cleo Breast, automating biomarker detection and reporting ~15% faster diagnostics.
The approval enables EU scale-up while the company prepares for future FDA entry.
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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.
Digital-Pathology-Today 