- No public price.
- Not disclosed
- Not disclosed
- —
- —
- DE
Pathology
Mindpeak
by Mindpeak · DE
AI decision support for pathologists scoring IHC slides: breast, PD-L1 and HER2 suites, plus tools for biopharma.
On this page
21/100Niche fit
- Regulatory & Compliance0/28
No FDA clearance listed
- Clinical Integration0/26
No EHR integrations listed
- Evidence Strength18.6/28.8
2 peer-reviewed papers
- Vendor & Market3/18
Seed-stage or unfunded
- 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 papers15/21
2 peer-reviewed papers
- RCT / meta-analysis / systematic review4/8
1 observational study (no RCT)
- Funding & adoption signal3/12
Seed-stage or unfunded
- 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
AI decision support for pathologists scoring IHC slides: breast, PD-L1 and HER2 suites, plus tools for biopharma.
No public price.
Bottom line
Mindpeak is a Hamburg company selling AI decision support for pathologists reading immunohistochemistry slides. Its lab products cover breast, PD-L1 and HER2, and it says 11 of its products are CE-IVD marked. It fits a European lab with digital slides that wants CE-marked IHC support. A US lab that needs an FDA-cleared product has nothing to buy here yet.
What is Mindpeak and who sells it?
Mindpeak GmbH sits at Zirkusweg 2 in Hamburg, with a US entity, Mindpeak Inc, at the Cambridge Innovation Center in Massachusetts. The homepage gives 2018 as the founding year.
A $3M seed round in 2019 (startupintros) preceded a $15.3M Series A, announced on 30 September 2024 and led by ZEISS Ventures and InnoVentureFund with AI.FUND and the EIC Fund, according to FinSMEs. Tracxn puts the total at $18.3M over four rounds, a figure that may include grants. Roche is named as a strategic partner.
What does Mindpeak sell?
For labs, the product list is peakDx, peakDissect, Breast Suite, PD-L1 Suite and HER2 Suite. For biopharma it has Phenoscout AI, peakDiscover, peakPredict and peakDeploy, and the platform layer is peakFrontier, which the company calls a "patented Pathology Frontier Model." The homepage says Mindpeak "transforms tissue into high-dimensional data."
Partners named on the homepage include Unilabs, Intermountain Health, Universitätsklinikum Erlangen, the Hamburg Institute for Hematopathology, Charité and Bio Reference Labs.
What is the regulatory status?
Mindpeak says it holds 11 CE-IVD products, runs an ISO 13485 quality management system, and has a certified penetration test. A headline on its site refers to IVDR certification. The same page states that "unless otherwise stated all products are intended for Research Use Only."
In the United States, the FDA 510(k) database lists no clearance for Mindpeak as of October 2026. The homepage says nothing about HIPAA, SOC 2 or HITRUST, which a lab sending patient slides to a vendor would ask about.
How much does Mindpeak cost?
There is no public price.
Is there independent validation?
Two peer-reviewed papers used the software. A 2025 Modern Pathology comparison of laboratory-developed Ki-67 tests against an FDA-approved benchmark, with a Mindpeak author on the paper, scored digitized slides with Mindpeak Breast Ki-67 alongside five pathologists. A 2023 JCPSP study uploaded hotspot images from 60 breast cancer cases into the Mindpeak software and reported strong concordance between automated and manual Ki-67 scoring. Neither paper is an independent validation of the product on its own.
Who is it for?
A European pathology lab already scanning slides and scoring breast markers by eye that wants a CE-IVD second opinion on each slide. A pharma team running biomarker studies on archived slides fits the biopharma side.
The verdict
Mindpeak is a credible European IHC vendor with ZEISS-led funding and named lab partners such as Unilabs and Charité. In the US it has no listed clearance, and independent validation of its algorithms has not been published.
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 the literature says
2 peer-reviewed studies indexed on PubMed evaluate Mindpeak in clinical contexts. The most relevant are shown below, ranked by editorial relevance score combining title match, study design, recency, and journal tier.
- Analytical Comparison of Commonly Used Laboratory-Developed Tests for the Assessment of Ki-67 in Breast Carcinoma With a Food and Drug Administration-Approved Benchmark.
- Badve S, White JS, Sapunar F, et al.· Mod Pathol· 2025
- Ki-67 immunohistochemistry (IHC), a commonly used assay for breast cancer risk prognostication, has significant interlaboratory heterogeneity. This study assessed the impact of antibody clones by comparing the Ki-67 IHC MIB-1 pharmDx assay (Dako Omnis; Agilent Technologies) with clones MIB-1 (Dako Autostainer Link 48 platform), K2 (Leica BOND-III platform), and 30-9 (Ventana BenchMark ULTRA platform) used in Ki-67 laboratory-developed IHC tests. Breast cancer tissue microarrays were processed and stained in 2 central laboratories per the manufacturer's instructions. Digitized images were asse…
- Ki-67 Quantification in Breast Cancer by Digital Imaging AI Software and its Concordance with Manual Method.
- Zehra T, Shams M, Ahmad Z, et al.· J Coll Physicians Surg Pak· 2023
- To validate the concordance of automated detection of Ki67 in digital images of breast cancer with the manual eyeball / hotspot method. Descriptive study. Place and Duration of the Study: Jinnah Sindh Medical University, Karachi, from 1st January to 15th February 2022. Glass slides of cases diagnosed as invasive ductal carcinoma (IDC) were obtained from the Agha Khan Medical University Hospital, selected retrospectively and randomly from 60 patients. They were stained with the Ki67 antibody. An expert pathologist evaluated the Ki67 index in the hotspot fields using eyeball method. Digital ima…
Other pathology
See the full pathology ranking
Tempus Digital Pathology
by Tempus AI
Digital pathology AI from Paige, now part of Tempus: Paige Prostate Detect (FDA De Novo, CE-IVDR) plus research-use suites.
No public price on the Tempus pages.|FDA De Novo (DEN200080) / FDA 510(k) (FullFocus viewer)
PathAI AISight
by PathAI
Cloud image management for digital pathology with AISight Dx, cleared for primary diagnosis, plus biopharma AI services.
No public price. Billing period, trial and refund not stated.|FDA 510(k)
Proscia Concentriq
by Proscia
Concentriq pathology platform for clinical labs and biopharma: image management, case review and AI apps, with FDA-cleared AP-Dx for primary diagnosis.
No public price. Demo request only.|FDA 510(k) / SOC 2 Type II (vendor announcement, 2025-12-03)
Ibex Medical Analytics
by Ibex
AI pathology software for prostate, breast and gastric cancer. One US FDA 510(k) clearance, for prostate.
No public price. Sold to laboratories and health systems on enterprise contracts.|FDA 510(k)