Ibex Medical Analytics vs Visiopharm
Ibex holds an FDA clearance and Visiopharm holds none, which sorts the US buyers at once. Ibex Prostate Detect was cleared in January 2025 as K241232, and the company also lists UK MHRA and ANVISA Brazil registrations. A US pathology department that wants cleared AI on prostate biopsies buys Ibex, since no Visiopharm product appears in the 510(k) database. Visiopharm suits an academic breast unit in the EU or UK scoring HER2-low, ER, PR and Ki-67, backed by a 2025 agreement study on its HER2 app, and it runs a research platform for pharma on the side. Ibex's breast and gastric tools are research use only in the US, so a US lab wanting cleared breast scoring gets it from neither. Grundium Oy announced its purchase of Visiopharm in May 2026 and describes its aim as scanners paired with analysis software. Visiopharm's roadmap under Grundium is not yet described.
Pathology · Reviewed November 1, 2026
Ibex Medical Analytics
by Ibex
AI pathology software for prostate, breast and gastric cancer. One US FDA 510(k) clearance, for prostate.
Visiopharm
by Visiopharm
Pathology image-analysis software with CE-IVD apps for breast, lung and prostate biomarkers and a research-use platform.
When to pick each one
Ibex Medical Analytics
- FDA 510(k) K241232 for prostate detection
- CE marked solutions plus UK MHRA registration
- Open API to scanners and LIS
Visiopharm
- Vendor cites nine IVDR-certified diagnostic algorithms
- HER2, ER, PR and Ki-67 scoring apps
- Lymph-node metastasis app for H&E slides, per vendor
Score
Each row shows points earned of points available under the published rubric.
Ibex Medical Analytics
33of 100
Visiopharm
43of 100
| Dimension | Ibex Medical Analytics | Visiopharm | Difference |
|---|---|---|---|
| FDA clearance | 18 / 18 | 0 / 18 | +18 |
| HIPAA / SOC2 / BAA | 0 / 10 | 0 / 10 | 0 |
| EHR integrations (count) | 0 / 4.2 | 0 / 4.2 | 0 |
| Top-3 EHR coverage (Epic / Oracle / Athena) | 0 / 2.4 | 0 / 2.4 | 0 |
| Peer-reviewed papers | 0 / 21 | 21 / 21 | -21 |
| RCT / meta-analysis / systematic review | 0 / 7.8 | 7.8 / 7.8 | -7.8 |
| Funding & adoption signal | 8.4 / 12 | 6 / 12 | +2.4 |
| Pricing transparency | 2.5 / 5 | 2.5 / 5 | 0 |
| Years in market | 0 / 6 | 0 / 6 | 0 |
Scroll horizontally to see every column.
Pricing
Ibex Medical Analytics
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. Sold to laboratories and health systems on enterprise contracts. |
Visiopharm
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
Evidence
Ibex Medical Analytics
FDA decisions
K241232 (opens in new tab)510(k)2025-01-24
Galen Second Read (Ibex Prostate Detect)
Visiopharm
FDA decisions
No FDA decision cited in our research as of October 20, 2026.
Peer-reviewed
5 PubMed records name Visiopharm.
- Inter-rater agreement of HER2-low scores between expert breast pathologists and the Visiopharm digital image analysis application (HER2 APP, CE2797). (opens in new tab)
- Clinical implementation of artificial-intelligence-assisted detection of breast cancer metastases in sentinel lymph nodes: the CONFIDENT-B single-center, non-randomized clinical trial. (opens in new tab)
- 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. (opens in new tab)
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | Ibex Medical Analytics | Visiopharm |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | n/a |
| HQ | IL | DK |
Scroll horizontally to see both columns.
Common questions
Open the full pathology comparison
Digital pathology workflows with FDA-cleared cancer detection (prostate, breast, colon), IHC scoring (HER2, Ki67), and AI-powered image management. Tempus, PathAI, Proscia dominate.