Healthcare · head to head
Lunit vs Therapixel

Lunit
Healthcare
FDA cleared and CE marked AI for mammography, tomosynthesis and chest radiography
- From
- On request
- Rated
- -
Therapixel
Healthcare
French mammography AI with FDA clearances for 2D and tomosynthesis breast screening
- From
- On request
- Rated
- -
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.; Therapixel european and American regulatory positions were established under different regimes, and under the EU Medical Device Regulation this class of diagnostic AI faces a higher classification and notified body scrutiny, so European buyers must verify the current MDR certificate and expiry rather than relying on a legacy CE reference.
- They diverge on capability: Lunit covers Lunit INSIGHT MMG, Therapixel covers MammoScreen 2D.
- Prices and features above were last checked on 1 September 2026.
Where they differ
Only the attributes on which Lunit and Therapixel actually diverge.
| Attribute | Lunit | Therapixel |
|---|
Identical on both: starting price (On request), pricing model (quote), free tier (No), platforms (Web), 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 Therapixel
- MammoScreen 2D
- MammoScreen DBT
- One to ten suspicion score
- Summary report
- Workstation and PACS delivery
- Reading workflow configurations
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 Therapixel
- A breast centre that moved to tomosynthesis and now has reading times it cannot staff, wanting detection support on DBT specificallynot Therapixel
- An American breast imaging centre needing automated volumetric density assessment to meet patient density notification requirements, which is what Volpara is bought fornot Therapixel
- A tuberculosis or lung screening programme in a high volume, radiologist scarce setting using chest radiography triage to prioritise filmsnot Therapixel
Therapixel
- A European breast screening programme running mandatory double reading that wants to evaluate AI as a concurrent or second reader within what national guidance permitsnot Lunit
- An American breast centre that has moved to tomosynthesis and needs reading support on DBT specifically, which Therapixel holds a clearance fornot Lunit
- A screening service wanting a graded suspicion score rather than a binary flag so readers can calibrate their own thresholdnot Lunit
- A radiology group evaluating multiple mammography AI vendors head to head on their own historic case set before committingnot 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.
Therapixel
- European and American regulatory positions were established under different regimes, and under the EU Medical Device Regulation this class of diagnostic AI faces a higher classification and notified body scrutiny, so European buyers must verify the current MDR certificate and expiry rather than relying on a legacy CE reference.
- MammoScreen does mammography only, so a hospital wanting AI across head CT, chest and breast needs several vendors and several PACS integrations, or an orchestration layer bought from someone else.
- Therapixel is a small French company competing against Hologic and iCAD, which have incumbency inside the mammography reading workstation, so integration into an American breast centre is more work than it is for the workstation vendor own AI.
- Detection performance is sensitive to the mammography unit vendor and acquisition protocol, so published results do not transfer between estates and each site needs local validation it must fund itself.
- Whether AI can substitute for one of two human readers is a national workforce and liability question, not a product capability, so the labour saving that justifies the purchase in one country is not permitted in another.
Pricing, plan by plan
Lunit
On request- Lunit INSIGHT$undefined/year
- Priced per study or per annual examination volume by product
- MMG, DBT and CXR licensed separately
- Volpara density and RiskPathways modules quoted separately
Therapixel
On request- MammoScreen$undefined/year
- Priced per examination or by annual screening volume
- 2D and tomosynthesis licensed by the versions cleared for each
- Cloud or on premises deployment quoted differently
Which should you pick?
Questions people ask
- Is Lunit or Therapixel better?
- Neither clearly leads. Lunit starts at On request and Therapixel at On request, and user ratings are close enough to be indistinguishable. Choose on capability and platform support.
- Which is cheaper, Lunit or Therapixel?
- Lunit starts at On request and Therapixel at On request.
- Does Lunit or Therapixel run on more platforms?
- Both run on Web, so platform support will not decide this one for you.
- 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 Therapixel is typically brought in for.
- What can Lunit do that Therapixel cannot?
- Lunit covers Lunit INSIGHT MMG, Lunit INSIGHT DBT, Lunit INSIGHT CXR, Volpara density assessment. Therapixel covers MammoScreen 2D, MammoScreen DBT, One to ten suspicion score, Summary report.
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.
Therapixel: Is MammoScreen FDA cleared?
Yes. It holds 510(k) clearance K192854 for two dimensional mammography from July 2020, a November 2021 clearance for digital breast tomosynthesis, and two further clearances in October 2024 for later versions.
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.
Therapixel: Is it CE marked?
Yes, but European buyers should ask specifically for the current certificate under the Medical Device Regulation and its expiry date, because this class of diagnostic AI moved to a higher classification under MDR.
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.
Therapixel: What does the one to ten score mean?
It is a graded suspicion score per finding and per study, designed to be integrated alongside a radiologist BI-RADS assessment rather than treated as a positive or negative result.
Lunit: Is pricing published?
No. It is quoted per study or per annual volume, by product, with on premises and cloud priced differently.
Therapixel: Does it cover anything besides mammography?
No. It is a mammography product only, including tomosynthesis. Other body regions need a different vendor.
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