- No public price. Sold to laboratories and health systems on enterprise contracts.
- Not disclosed
- Not disclosed
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- —
- IL
Pathology
Ibex Medical Analytics
by Ibex · IL
AI pathology software for prostate, breast and gastric cancer. One US FDA 510(k) clearance, for prostate.
On this page
32/100Competitive
- Regulatory & Compliance18/28
FDA cleared (1 K-number on record)
- Clinical Integration0/26
No EHR integrations listed
- Evidence Strength8.4/28.8
1 peer-reviewed paper
- Vendor & Market8.4/18
Mid-tier funding and adoption
- Sentiment & Transparency2.5/14
Pricing on request, no public amounts
▸ Show all 11 dimensions▾ Hide dimension detail
- FDA clearance18/18
FDA cleared (1 K-number on record)
- 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 papers8/21
1 peer-reviewed paper
- RCT / meta-analysis / systematic review0/8
No RCT, meta-analysis, or systematic review
- Funding & adoption signal8/12
Mid-tier funding and adoption
- 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
Most-deployed AI pathology platform globally.
Israeli-origin. Prostate, breast, colon focus. Broad EU + US deployments.
Bottom line
Ibex Medical Analytics sells AI that reads digitized pathology slides and flags cancer for the pathologist. In the United States it holds one FDA clearance, for prostate. Its breast and gastric products are, by the vendor's own statement, research use only there. It is enterprise software priced by quote, so it fits a pathology lab or health system with a digital scanner workflow. A lab that needs a cleared breast or gastric product in the US cannot buy one from Ibex today.
What is Ibex and who sells it?
Ibex describes its offer as "field-proven, AI-powered diagnostic solutions" that help pathologists "ensure better cancer care" (Ibex website). The platform covers breast, prostate and gastric cancer, plus "more than a hundred other clinically relevant features" (Ibex solutions page). The named products are Ibex Prostate, Ibex Breast, Ibex Breast HER2 and Ibex Gastric. The prostate product was previously sold as Galen.
The company is Ibex Medical Analytics Ltd. in Tel Aviv, Israel. Tracxn and Nocamels give 2016 as the founding year and name Joseph Mossel as CEO and Chaim Linhart as co-founder. Ibex raised an $11 million Series A in March 2019 from aMoon, a $38 million Series B in 2021 (Forbes, 2021) and a $55 million Series C in September 2023 led by 83North (FeedTheAI).
What is actually cleared by the FDA?
The prostate product, Galen Second Read (now Ibex Prostate Detect), received 510(k) clearance K241232. The FDA received the submission on May 2, 2024 and decided on January 24, 2025. It was a Traditional 510(k) with a "Substantially Equivalent" decision under product code QPN. The vendor says its other solutions are "Research Use Only (RUO) in the United States and not cleared by the FDA" (Ibex solutions page).
Outside the US, Ibex lists CE marking under the IVDD for several solutions, IVDR CE marking for Ibex First Read in prostate, and registrations with the UK MHRA and Brazil's ANVISA.
What does the evidence show?
Ibex says its algorithms were "developed from rich datasets extracted from over 10 million slides", which is the vendor's claim. The FDA decision gives the most concrete figures, relayed by Urology Times: a 99.6 percent positive predictive value for heatmap accuracy, and a finding that pathologists working without the AI missed 13 percent of the cancers the AI found.
Independent literature is thin. A 2025 narrative review in Cesk Patol (PMID 40763009, Sebestova et al.) names IBEX alongside Roche uPath but reports no performance data for Ibex alone. A prostate validation at UPMC (Pantanowitz) appears on the Ibex site as a vendor-selected reference.
How does it connect to a lab?
Ibex offers an open API for integration with digital pathology software, scanners and laboratory information systems. Integration runs through scanners, image management and the LIS, and the vendor names no EHR connection. HIPAA, SOC 2 and HITRUST status are not stated on the vendor's pages.
Pricing
Ibex publishes no price. It sells to laboratories and health systems on enterprise contracts.
Who is it for?
A pathology department that already scans slides and wants a second reader for prostate biopsies is the clear fit, since that is the cleared use. A lab outside the US has a wider menu, because CE marking covers several solutions and Ibex First Read in prostate carries IVDR marking.
The verdict
Ibex is a credible prostate second-read product with a real FDA clearance, and its breadth claims run ahead of its US regulatory scope. It belongs in a prostate service that already has digital slides.
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. Sold to laboratories and health systems on enterprise contracts. |
Source: vendor pricing page. Last checked October 15, 2026.
What deploys cleanly
Carries FDA 510(k) per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.
What the literature says
1 peer-reviewed study indexed on PubMed evaluate Ibex Medical Analytics in clinical contexts. The most relevant are shown below, ranked by editorial relevance score combining title match, study design, recency, and journal tier.
- Utilization of Artificial Intelligence Algorithms for the Diagnosis of Breast, Lung, and Prostate Cancer.
- Šebestová G, Klinger T, Švajdler M, et al.· Cesk Patol· 2025
- The study focuses on the utilization of artificial intelligence (AI) algorithms in the diagnosis of breast, lung, and prostate cancer. It describes the historical development of the digitalization of pathological processes, the implementation of artificial intelligence, and its current applications in pathology. The study emphasizes machine learning, deep learning, computer vision, and digital pathology, which contribute to the automation and refinement of diagnostics. Special attention is given to specific tools such as the uPath systems from Roche and IBEX Medical Analytics, which enable th…
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