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Healthcare · head to head

Lunit vs OpenClinica

Lunit logo

Lunit

Healthcare

FDA cleared and CE marked AI for mammography, tomosynthesis and chest radiography

From
On request
Rated
-
Full reviewWebsite
OpenClinica logo

OpenClinica

Healthcare

Clinical trial EDC with a genuinely open source community edition alongside a quoted commercial platform

From
On request
Rated
-
Full reviewWebsite

The short version

  • Each has a real cost: Lunit the regulatory permission differs by product and by region, and INSIGHT Risk has been filed with the FDA but not cleared, so a buyer who reads a corporate press release rather than the specific clearance for their product and jurisdiction will plan a deployment they cannot legally run.; OpenClinica the free community edition is a different and older product line from the commercial platform, so evaluating the open source build tells you little about what the paid product actually does.
  • They diverge on capability: Lunit covers Lunit INSIGHT MMG, OpenClinica covers Open source community edition.
  • Prices and features above were last checked on 1 September 2026.

Where they differ

Only the attributes on which Lunit and OpenClinica actually diverge.

Attributes where Lunit and OpenClinica differ
AttributeLunitOpenClinica
PlatformsWebWeb, Self-hosted, iOS, Android

Identical on both: starting price (On request), pricing model (quote), free tier (No), user rating (Not yet rated), category (Healthcare).

What each one covers

Drawn from each product's published feature list. An absence here means we hold no record of it - not that the product lacks it.

Only in Lunit

  • Lunit INSIGHT MMG
  • Lunit INSIGHT DBT
  • Lunit INSIGHT CXR
  • Volpara density assessment
  • Volpara RiskPathways
  • Volpara dose tracking
  • PACS and mammography workstation integration

Only in OpenClinica

  • Open source community edition
  • Electronic data capture
  • eConsent
  • eCOA and ePRO
  • Randomisation
  • EHR-to-EDC
  • Audit trail
  • Reporting and analytics

What people use each for

The jobs each tool is most often brought in to do.

Lunit

  • A national breast screening programme evaluating AI as a second reader to reduce double reading workload where two human readers are currently mandatednot OpenClinica
  • A breast centre that moved to tomosynthesis and now has reading times it cannot staff, wanting detection support on DBT specificallynot OpenClinica
  • An American breast imaging centre needing automated volumetric density assessment to meet patient density notification requirements, which is what Volpara is bought fornot OpenClinica
  • A tuberculosis or lung screening programme in a high volume, radiologist scarce setting using chest radiography triage to prioritise filmsnot OpenClinica

OpenClinica

  • An academic coordinating centre running investigator-initiated trials that needs Part 11 compliant capture without an enterprise eClinical budgetnot Lunit
  • A registry or observational cohort study collecting structured data across many sites over yearsnot Lunit
  • A small device sponsor that needs eConsent and ePRO in the same system as its case report formsnot Lunit
  • An informatics group that wants to self-host the open source edition for a non-regulated internal studynot Lunit

Where each one falls short

Documented limitations, not opinions. Every one is a constraint you would hit in normal use.

Lunit

  • The regulatory permission differs by product and by region, and INSIGHT Risk has been filed with the FDA but not cleared, so a buyer who reads a corporate press release rather than the specific clearance for their product and jurisdiction will plan a deployment they cannot legally run.
  • Detection AI changes recall rates in screening, and the downstream cost of additional diagnostic workup lands on the programme rather than on the software budget, which is the cost most screening business cases omit.
  • Performance is sensitive to the mammography vendor and acquisition protocol, so published results from a Hologic estate do not transfer to a GE or Siemens estate without local validation the buyer must fund.
  • MMG, DBT and CXR are licensed separately and Volpara modules are separate again, so a breast centre wanting detection, density and risk pathways is assembling four line items rather than buying one product.
  • Using AI as a replacement for one of two human readers is a workforce and liability decision that regulators and professional bodies treat differently in each country, so the saving that justifies the purchase may not be permitted where you operate.

OpenClinica

  • The free community edition is a different and older product line from the commercial platform, so evaluating the open source build tells you little about what the paid product actually does.
  • The vendor provides no support or services at all for the community edition, which means outages, patching, database upgrades and validation documentation are entirely your problem.
  • Commercial pricing is not published, so you cannot benchmark it against alternatives without entering a sales process, and third-party figures around USD 1,000 a month are indicative rather than contractual.
  • Study build is skilled work: complex edit checks, randomisation schemes and integrations usually mean paying for vendor or consultant configuration services on top of the licence, which is a frequently underestimated line in the budget.
  • As a smaller vendor than the large eClinical suites it has a thinner partner and consultant ecosystem, so finding experienced build staff or a CRO already fluent in the platform is harder than with the market incumbents.

Pricing, plan by plan

Lunit

On request
  • Lunit INSIGHT$undefined/year
    • Priced per study or per annual examination volume by product
    • MMG, DBT and CXR licensed separately
    • Volpara density and RiskPathways modules quoted separately

OpenClinica

On request
  • Community Edition$undefined/year
    • Free and open source under the LGPL
    • Self-hosted, on the older 3.x line
    • No vendor support or services of any kind
  • OpenClinica Enterprise$undefined/year
    • Pricing only through a sales process
    • Hosted and validated instance
    • EDC, eConsent, eCOA, randomisation and analytics modules

Which should you pick?

Choose Lunit if

  • You need lunit insight mmg.
  • You also want lunit insight dbt.
Lunit review

Choose OpenClinica if

  • You need open source community edition.
  • You work on Web, Self-hosted, iOS, Android.
  • You also want electronic data capture.
OpenClinica review

Questions people ask

Is Lunit or OpenClinica better?
Neither clearly leads. Lunit starts at On request and OpenClinica at On request, and user ratings are close enough to be indistinguishable. Choose on capability and platform support.
Which is cheaper, Lunit or OpenClinica?
Lunit starts at On request and OpenClinica at On request.
Does Lunit or OpenClinica run on more platforms?
Lunit runs on Web. OpenClinica runs on Web, Self-hosted, iOS, Android.
What is Lunit best used for?
Lunit is most often used for a national breast screening programme evaluating ai as a second reader to reduce double reading workload where two human readers are currently mandated, a breast centre that moved to tomosynthesis and now has reading times it cannot staff, wanting detection support on dbt specifically, an american breast imaging centre needing automated volumetric density assessment to meet patient density notification requirements, which is what volpara is bought for, a tuberculosis or lung screening programme in a high volume, radiologist scarce setting using chest radiography triage to prioritise films. Of those, a national breast screening programme evaluating ai as a second reader to reduce double reading workload where two human readers are currently mandated and a breast centre that moved to tomosynthesis and now has reading times it cannot staff, wanting detection support on dbt specifically are not what OpenClinica is typically brought in for.
What can Lunit do that OpenClinica cannot?
Lunit covers Lunit INSIGHT MMG, Lunit INSIGHT DBT, Lunit INSIGHT CXR, Volpara density assessment. OpenClinica covers Open source community edition, Electronic data capture, eConsent, eCOA and ePRO.

Answered from the vendors’ own pages

Lunit: Is Lunit FDA cleared?

Yes for specific products. INSIGHT MMG, INSIGHT DBT and INSIGHT CXR Triage hold FDA 510(k) clearances. INSIGHT Risk, the five year risk prediction model, has been filed but was not cleared at the time of writing.

OpenClinica: Is OpenClinica free?

There is a genuinely free, LGPL licensed community edition you host yourself with no vendor support. The commercial platform with eConsent, eCOA and a validated hosted instance is quoted and paid.

Lunit: Can Lunit replace a second human reader in screening?

That depends entirely on your jurisdiction and professional body guidance, not on the software. The CE mark permits clinical use; it does not authorise a workforce model.

OpenClinica: Is the open source version still maintained?

Yes, releases on the 3.x line continued through 2025, but it is a separate and older architecture from the commercial product.

Lunit: What did the Volpara acquisition add?

Volumetric breast density measurement, dose tracking and RiskPathways high risk programme management, which are the things American breast centres buy for density notification compliance rather than for detection.

OpenClinica: Does it meet 21 CFR Part 11?

The commercial hosted platform is built for Part 11 and GCP compliance. If you self-host the community edition, compliance and validation are entirely your responsibility.

Lunit: Is pricing published?

No. It is quoted per study or per annual volume, by product, with on premises and cloud priced differently.

OpenClinica: What does the commercial version cost?

Not published. Third-party listings suggest enterprise arrangements from around USD 1,000 per month, but real cost depends on study count, subjects, modules and build services.

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