MedAI Verdict
Pathology

AI Pathology

Aignostics

by Aignostics  ·  DE

Last verified

Pathology foundation models and tissue analysis for drug development and biomarker research, spun out of Charité Berlin.

At a glance

Pricing
No public price. The product is sold to biopharma and research customers.
HIPAA
Not disclosed
SOC 2
Not disclosed
EHRs
—
Founded
—
HQ
DE
On this page

Independent score  ·  By our public rubric

5/100Tracked
How it’s computed →
  • Regulatory & Compliance
    0/28

    No FDA clearance listed

  • Clinical Integration
    0/26

    No EHR integrations listed

  • Evidence Strength
    0/28.8

    No peer-reviewed coverage

  • Vendor & Market
    3/18

    Seed-stage or unfunded

  • Sentiment & Transparency
    2.5/14

    Pricing on request, no public amounts

▸ Show all 11 dimensions

Regulatory & Compliance

  • FDA clearance0/18

    No FDA clearance listed

  • HIPAA / SOC2 / BAA0/10

    No public HIPAA/SOC2/BAA attestation

Clinical Integration

  • 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

Evidence Strength

  • Peer-reviewed papers0/21

    No peer-reviewed coverage

  • RCT / meta-analysis / systematic review0/8

    No RCT, meta-analysis, or systematic review

Vendor & Market

  • Funding & adoption signal3/12

    Seed-stage or unfunded

  • Years in market0/6

    Founded year not recorded

Sentiment & Transparency

  • Clinician sentiment (Reddit)0/9

    No clinician sentiment data available

  • Pricing transparency3/5

    Pricing on request, no public amounts

Scored October 15, 2026 · Public scoring method v1.1.0

Bottom line

Pathology foundation models and tissue analysis for drug development and biomarker research, spun out of Charité Berlin.

No public price. The product is sold to biopharma and research customers.

Editorial review  ·  By MedAI Verdict

Bottom line

Aignostics, with offices in Berlin and New York, sells pathology AI to pharmaceutical and biotech teams and to research groups. Its site gives the mission as "to transform drug development", and its products cover tumor microenvironment profiling, case search by tissue morphology and foundation models for customers who train their own classifiers. FDA's 510(k) database lists no device from Aignostics, and the audience on the site is drug development. Aignostics sells by quote.

Who buys what Aignostics sells?

The site addresses drug developers running translational studies, biomarker programs and clinical trials, plus research groups. Its tagline reads "Turning complex biomedical data into transformative insights". The services list covers target and biomarker discovery, translational research and digital diagnostics, and the site advertises a "GCP-ready clinical trial platform". An Aignostics-Bayer Target ID Platform appears there too, which reflects a strategic collaboration with Bayer.

The site lists three products:

  • PathoSearch is a visual search tool that retrieves diagnosed reference cases with similar morphology.
  • Atlas H&E-TME profiles the tumor microenvironment on Aignostics' own foundation model.
  • The pathology foundation models provide embeddings for custom training.

HETA, a tumor microenvironment analysis built on Atlas 2, was developed together with Mayo Clinic.

Who is behind it?

Aignostics is a spin-out of Charité Berlin. A Series B of $34 million in October 2024 was led by ATHOS, with Mayo Clinic and HTGF taking part, according to the investment promotion agency Berlin Partner. Bayer appears as a strategic collaborator, and the Target ID Platform carries both company names on the site. The site claims access to data from more than 30 million patients.

What certifications does it list?

The site states ISO 13485 and ISO 27001 certification, covering quality management for medical devices and information security. It does not mention a CE mark, HIPAA or SOC 2.

How is Aignostics sold?

Aignostics shows no figure, plan or billing period, and no trial or refund terms. The offer mixes software with services, so a quote covers a project as well as a product.

The verdict

A biopharma translational team that wants tissue-image analysis inside a drug program is the buyer the site describes, and the Series B, the ISO certifications and the Mayo Clinic work on HETA sit behind that offer. A hospital pathology lab that wants cleared software to sign out patient slides has no FDA-listed Aignostics product to buy.

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.

Pricing

What it costs

All tiers are custom-quoted. The vendor does not publish per-provider list pricing.

TierMonthlyAnnualNotes
Quote only——No public price. The product is sold to biopharma and research customers.

Source: vendor pricing page. Last checked October 15, 2026.

Compliance + integration

What deploys cleanly

Carries ISO 13485, ISO 27001 per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.