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Visiopharm Insight

by Visiopharm

AI Application
Low Confidence

Insight is Visiopharm's line of IVDR-certified image-analysis apps (APPs) for diagnostic pathology, used by pathologists in hospital laboratories on digitised slides. The vendor lists CE-IVD APPs for ER, PR, Ki-67 and HER2 in breast cancer, PD-L1 in non-small-cell lung cancer, a hot-spot tool, and an AI app that detects metastases in H&E-stained lymph nodes from breast and colorectal adenocarcinoma, marks them as high, medium or low probability, measures the largest metastasis and sorts slides so those with findings are reviewed first. The vendor says the APPs analyse the whole slide without manual interaction, so results are ready for the pathologist's review, and show how close a score is to clinical cut-offs; the pathologist makes the diagnosis. Insight runs on the web, on-premise or hybrid and integrates with Sectra, Philips, Proscia, PathAI, Fujifilm and other image-management systems. Visiopharm separately sells Qualitopix, a research-use web service that uses AI to measure immunohistochemistry staining intensity for quality control.

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Transparency Score

Weighted across four pillars · updated October 20, 2026

Overall grade
27% weighted
ABCDF
Model
—
Not yet assessed
Infrastructure
—
Not yet assessed

Capabilities

Lymph Node Metastasis Detection
Biomarker Quantification
Her2 Scoring
Ki67 Scoring
Pd L1 Scoring
Slide Prioritisation

Vendor Information

Complete information about the vendor/provider of this AI application

VisiopharmView all products →
Visiopharm A/S(Trading as: Visiopharm)
Contact Information
visiopharm.com
Registered Address
Agern Allé 24, Hørsholm, Capital Region of Denmark, 2970, DK

EU AI Act Provider Information

Verification Status:
Unverified
Visiopharm A/S(Trading as: Visiopharm)
Agern Allé 24, Hørsholm, Capital Region of Denmark, 2970, DK
Compliance Documents
CE Marking: Certified
Notified Body: BSI Group The Netherlands B.V.(Cert: IVDR 742024)
Visiopharm says its CE-IVD APPs are for in vitro diagnostic use in the EU and UK and are not for sale in the USA, and its site-wide disclaimer reads 'Unless otherwise stated all products are Research Use Only, not for use in diagnostic procedures' (https://visiopharm.com/diagnostics-pathology-image-analysis-software/, read 2026-10-20). It says the Metastasis Detection app is 'optimized for maximum sensitivity' (https://visiopharm.com/app-center/app/metastasis-detection-ai/, read 2026-10-20). No contraindications are published.
Compliance & Risk

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Added: October 20, 2026
Updated: October 20, 2026

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