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- DK
Pathology
Visiopharm
by Visiopharm · DK
Pathology image-analysis software with CE-IVD apps for breast, lung and prostate biomarkers and a research-use platform.
On this page
32/100Competitive
- Regulatory & Compliance0/28
No FDA clearance listed
- Clinical Integration0/26
No EHR integrations listed
- Evidence Strength28.8/28.8
5 peer-reviewed papers
- Vendor & Market6/18
Early-stage company
- Sentiment & Transparency2.5/14
Pricing on request, no public amounts
▸ Show all 11 dimensions▾ Hide dimension detail
- FDA clearance0/18
No FDA clearance listed
- HIPAA / SOC2 / BAA0/10
No public HIPAA/SOC2/BAA attestation
- EHR integrations (count)0/14
No EHR integrations listed
- Top-3 EHR coverage (Epic / Oracle / Athena)0/8
None of the top-3 EHRs covered
- Bidirectional write-back0/4
No bidirectional write-back documented
- Peer-reviewed papers21/21
5 peer-reviewed papers
- RCT / meta-analysis / systematic review8/8
1 RCT/Meta-Analysis/Systematic Review
- Funding & adoption signal6/12
Early-stage company
- Years in market0/6
Founded year not recorded
- Clinician sentiment (Reddit)0/9
No clinician sentiment data available
- Pricing transparency3/5
Pricing on request, no public amounts
Pathology image-analysis software with CE-IVD apps for breast, lung and prostate biomarkers and a research-use platform.
No public price.
Bottom line
Visiopharm sells digital pathology image-analysis software in two lines: research-use-only analysis for pharma and academia, and diagnostic apps that the vendor says are certified in Europe under the IVDR. It fits a pathology lab in the EU or UK that wants HER2, ER, PR or Ki-67 scoring on whole slide images. It does not currently fit a US lab that needs FDA-cleared algorithms, because no FDA clearance for any Visiopharm product appears in the database.
Is Visiopharm FDA-cleared?
No FDA clearance appears in the 510(k) database, which returned no match for Visiopharm as applicant in October 2026. The homepage and the acquisition press release make no FDA claim, and both state that unless otherwise stated all products are research use only and not for diagnostic procedures. An older Visiopharm release, from about 2023, said the company was fully committed to obtaining FDA clearance. No K-number has appeared since.
The diagnostic status is CE-IVD under the EU's In Vitro Diagnostic Regulation, on the vendor's word. The homepage promises IVDR-certified apps for biomarker assessment in breast, lung and prostate cancer, and the acquisition release says "no fewer than nine diagnostic algorithms" are cleared under IVDR for EU and UK customers. A February 2022 vendor release claimed the first IVDR certification in digital pathology. Notified body and certificate numbers are not published, so a buyer should ask for them. The company's ISO 13485:2016 certificate is linked on the homepage and valid until December 27, 2027.
Who sells it?
Visiopharm A/S is based in Hørsholm, Denmark and was founded in 2002. On May 21, 2026 it announced that Grundium Oy, a Finnish company from Tampere founded in 2015 and backed by EW Healthcare Partners, would acquire it, with terms undisclosed. Michael Grunkin is CEO. Grundium's stated aim is an integrated platform pairing scanners with analysis, and the homepage already lists a Grundium scanner pairing. What the deal does to product roadmap and pricing is unknown.
What does it do?
The diagnostic apps cover ER, PR, HER2 and Ki-67 scoring on immunohistochemistry slides, and the vendor lists a lymph-node metastasis detection algorithm for H&E slides among them. The research platform provides image analysis for studies. The homepage describes integrations with image management and laboratory information systems, including PACS-IMS links. EHR integration, HIPAA, SOC 2 and HITRUST are not stated.
What does the evidence say?
A 2025 paper in the Journal of Pathology: Clinical Research measured agreement on HER2-low scores between expert breast pathologists and the Visiopharm HER2 app (CE2797). A 2025 Modern Pathology study compared two AI tools for lymph node metastases and mentions Visiopharm. The homepage also names lung and prostate apps, but the published studies here cover breast and lymph node work.
The University Medical Centre Utrecht implementation is described in a vendor release. No independent user reviews for 2025 or 2026 are published.
What does it cost?
Visiopharm lists no price and sells per module to institutions.
Who is it for?
An academic breast pathology unit in Denmark or the Netherlands standardizing HER2-low reporting is the clearest customer. A US community lab with one scanner is not, until a clearance exists. Pharma teams running tissue studies can use the research side without any clearance question. A lab that wants one vendor relationship for scanning and analysis could look at the Grundium scanner pairing the homepage lists, though the combined roadmap is not described.
The verdict
Visiopharm is a credible European diagnostic vendor with a published HER2-low agreement study and, by its own count, nine IVDR-certified apps. If you practice in the US, ask for the 510(k) number first. If they cannot give you one, you are buying a research tool.
Editorial review last generated October 15, 2026. Synthesized from clinician sentiment, peer-reviewed coverage, and our editorial silo picks. Refined by hand where vendor facts change.
What it costs
All tiers are custom-quoted. The vendor does not publish per-provider list pricing.
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | — | — | No public price. |
Source: vendor pricing page. Last checked October 15, 2026.
What deploys cleanly
Carries CE-IVD (IVDR), ISO 13485:2016 per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.
What the literature says
5 peer-reviewed studies indexed on PubMed evaluate Visiopharm in clinical contexts. The most relevant are shown below, ranked by editorial relevance score combining title match, study design, recency, and journal tier.
- Inter-rater agreement of HER2-low scores between expert breast pathologists and the Visiopharm digital image analysis application (HER2 APP, CE2797).
- Parry S, Zabaglo L, Shaaban AM, et al.· J Pathol Clin Res· 2025
- Inter-observer concordance data for the HER2 category as assessed by a group of 16 specialist breast pathologists on 50 diagnostic core biopsies was compared with that produced by digital image analysis (DIA) using the HER2 APP, CE2797 (VP APP; Visiopharm, Hoersholm, Denmark). Comparing pathologists' consensus scores and DIA scores, 36 cases (73.5%) agreed. Fleiss' kappa statistic was 0.433 (indicative of moderate agreement). Cohen's weighted kappa was used to compare the scores of individual raters to consensus scores; for all 50 cases the kappa scores had a range between 0.412 and 0.854; th…
- Clinical implementation of artificial-intelligence-assisted detection of breast cancer metastases in sentinel lymph nodes: the CONFIDENT-B single-center, non-randomized clinical trial.
- van Dooijeweert C, Flach RN, Ter Hoeve ND, et al.· Nat Cancer· 2024
- Pathologists' assessment of sentinel lymph nodes (SNs) for breast cancer (BC) metastases is a treatment-guiding yet labor-intensive and costly task because of the performance of immunohistochemistry (IHC) in morphologically negative cases. This non-randomized, single-center clinical trial (International Standard Randomized Controlled Trial Number:14323711) assessed the efficacy of an artificial intelligence (AI)-assisted workflow for detecting BC metastases in SNs while maintaining diagnostic safety standards. From September 2022 to May 2023, 190 SN specimens were consecutively enrolled and a…
- Head-to-Head Comparison of 2 Artificial Intelligence Tools for Detecting Lymph Node Metastases in Whole-Slide Pathology Images Within and Beyond Their Intended Use.
- Flach RN, Samuels M, Ter Hoeve ND, et al.· Mod Pathol· 2025
- The increasing diagnostic workload in pathology, driven by rising cancer incidences, highlights the need for scalable, cost effective solutions. Artificial intelligence (AI) has shown promise in supporting lymph node (LN) metastasis detection, a key prognostic factor in cancer staging. However, the current Conformité Européene In Vitro Diagnostics--certified AI tools are often limited to specific tumor types, reducing their cost efficiency and clinical use. This study evaluates the performance of 2 Conformité Européene In Vitro Diagnostics-certified AI tools-Visiopharm Met…
- AI for pathologists: a universal lymph node metastasis detection app that enhances efficiency while preserving diagnostic accuracy.
- Vazzano J, Challa B, Arole V, et al.· J Pathol Clin Res· 2026
- Increasing workload combined with the shortage of pathologists is the leading cause of diagnostic errors and delays. Nonetheless, in clinical practice, pathologists often spend hours on tedious tasks such as counting mitoses and searching for lymph node micro-metastasis, which may yield unreliable results. The advent of digital pathology and the development of artificial intelligence (AI) applications (app) for image analysis have opened new possibilities for improving the efficiency and accuracy of pathologists. However, the perceived black box nature of AI has led to skepticism among many p…
- Implementation of artificial intelligence to automate physical disector in a fractionator design for quantification of stem cell-derived neurons.
- Overgaard A, Molnár K, Jurtz VI, et al.· Comput Biol Med· 2026
- Accurate quantification of stem cell-derived dopaminergic neurons is essential for advancing cell therapy strategies in Parkinson's disease (PD). Traditional manual stereological methods, while robust, are time-consuming and subject to interobserver variability, limiting their scalability for preclinical and translational studies. This study presents the development and validation of an artificial intelligence (AI)-assisted physical fractionator workflow for unbiased and efficient quantification of human embryonic stem cell (hESC)-derived ventral midbrain dopaminergic (vmDA) neurons in a Park…
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