MedAI Verdict
Radiology

AI Radiology

Vara Mammography

by MX Healthcare GmbH  ·  DE

Last verified

AI second reader for mammography screening that flags missed findings and pre-reports normal cases. CE Class IIb.

At a glance

Pricing
No public price. The site shows no plan, billing period or trial.
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
    0/26

    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 papers0/18

    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

AI second reader for mammography screening that flags missed findings and pre-reports normal cases. CE Class IIb.

No public price. The site shows no plan, billing period or trial.

Editorial review  ·  By MedAI Verdict

Bottom line

Vara is a Berlin company whose software reads mammograms as a second reader and triages normal cases. Vara says it holds a CE mark as a Class IIb device, and the FDA's 510(k) database lists no entry for it, so a US practice cannot use it as a cleared product. In Europe it is a screening-programme product, and Vara claims use in more than half of Germany's national breast screening programme.

What is Vara and who sells it?

Vara describes its product as "CE-marked, autonomous AI for breast cancer screening and diagnostic reading", with the line "Human Expertise, Amplified". The company is based in Berlin and was co-founded by Jonas Muff, the CEO, and Stefan Bunk, the CTO. A Series A extension of EUR 4.5 million in October 2022 brought the Series A total to EUR 11 million, led by VI Partners with EQT Foundation and Med360, according to Silicon Canals. Merantix, Think.Health, Soleria and Plug and Play also took part.

What does it do in a screening workflow?

Vara's product pages list these functions.

  • Safety Net flags potentially missed findings on every case.
  • Normal case triage pre-reports normal exams, and Vara says 80% of normal cases can be handled this way. Reports for unremarkable exams can be generated automatically.
  • Thresholds are adjustable, and findings come with lesion-level context.
  • ATMON compares the software's predictions with the performance of each site and can send a site back to full radiologist reading if the numbers drift. Vara says ATMON data cover seven years and 7.2 million reads.
  • Digital breast tomosynthesis is supported.

Vara describes PACS integration, a viewer workflow and a plugin for existing systems. Its security wording is "secure by design", with no standard named.

Is there published evidence?

Vara cites the PRAIM study, a real-world study published in Nature Medicine in 2024, in support of its screening claims.

Is Vara available in the US?

The FDA's 510(k) database has no entry for Vara, Vara GmbH, Merantix or Merantix Healthcare, and Vara's page names the CE mark only. For a European screening programme, CE marking is the relevant route.

How is Vara sold?

Vara's site gives no figure, and no billing period or trial terms.

The verdict

Vara suits a European breast screening service that wants an AI second reader with a built-in monitor that can pull a site back to full human reading. A US practice that needs an FDA-cleared product cannot buy Vara as one.

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 site shows no plan, billing period or trial.

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

Compliance + integration

What deploys cleanly

Carries CE Class IIb (vendor-stated) per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.