Lunit

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

As of 1 September 2026, Lunit's pricing is not published; the vendor quotes on request. Lunit sells detection AI for breast and chest imaging, and it now owns Volpara, which puts breast density assessment and risk pathways in the same portfolio. Softwr lists it under Healthcare. Lunit is made by Lunit Inc., available on Web.

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Overview

What Lunit does

Lunit is a South Korean medical AI company selling image analysis software for cancer screening. The main products are Lunit INSIGHT MMG for two dimensional mammography, Lunit INSIGHT DBT for digital breast tomosynthesis, and Lunit INSIGHT CXR for chest radiography, with a CXR Triage variant cleared in the United States. Lunit acquired Volpara Health, which added breast density measurement, dose tracking and the RiskPathways programme management tooling used by American breast centres. Lunit has also filed a 510(k) for INSIGHT Risk, a mammography based five year breast cancer risk prediction model, which was not cleared at the time of writing. The distinguishing fact is that the regulatory permission is product specific and region specific, and Lunit is one of the few AI vendors holding both FDA 510(k) clearances and CE marks under the European Medical Device Regulation across a screening portfolio deployed in more than sixty countries. A European breast screening programme and an American breast centre are therefore buying genuinely different permissions from the same catalogue, and a buyer who reads a global press release rather than the specific clearance for their product and jurisdiction will misjudge what they can deploy. Buyers are national and regional breast screening programmes, hospital radiology departments and, increasingly through Volpara, American breast imaging centres that need density notification compliance. The trade off is that detection AI in screening changes recall rates, and a programme that deploys Lunit without a plan for the resulting change in recalls and downstream diagnostic workup will import a cost it did not model. Screening AI is an operations decision before it is a software decision.

What people use it 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

Where it falls short

Concrete and checkable, so you can decide whether any of them matter to you. This is the half of a review a vendor will not write about 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.

Cross-shopped

What people choose instead of Lunit

Each pairing was judged by two reviewers asking whether a buyer would genuinely weigh the two against each other. The ones that failed were deleted rather than published.

Lunitvs
Therapixel
Therapixel: Therapixel MammoScreen is a narrower mammography only option with its own FDA clearances including tomosynthesis
Lunitvs
Aidoc
Aidoc: Aidoc suits acute triage across head, chest and abdomen rather than cancer screening workflows

Pricing

What Lunit costs

Taken from the vendor's own pricing page. Prices move, so check before you buy.

Lunit INSIGHT

On request

Priced per study or per annual examination volume by product
MMG, DBT and CXR licensed separately
Volpara density and RiskPathways modules quoted separately
On premises or cloud deployment, priced differently
No published rate card

Capabilities

Features

Lunit INSIGHT MMG
Detection and localisation of suspicious lesions on two dimensional mammography with an abnormality score
Lunit INSIGHT DBT
Equivalent detection on digital breast tomosynthesis, addressing the reading time problem tomosynthesis created
Lunit INSIGHT CXR
Detection of multiple abnormality types on chest radiographs, with a separately cleared Triage variant in the United States
Volpara density assessment
Automated volumetric breast density measurement supporting patient density notification requirements
Volpara RiskPathways
Programme management for high risk breast patients, tracking supplemental screening and follow up
Volpara dose tracking
Records radiation dose per mammographic examination for quality programmes
PACS and mammography workstation integration
Results delivered into standard reading environments as secondary capture or structured findings

Answered, with sources

Questions people ask

Each answer names the page it came from, so you can check it rather than take our word for it.

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.

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.

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.

Is pricing published?

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

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Softwr does not host reviews and shows no star rating for Lunit, because a rating we did not collect is not ours to publish. What is here is the pricing and platform detail from the vendor’s own pages, limitations we could state concretely, and alternatives a reviewer confirmed people weigh against it. Tell us if any of it is wrong.

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