Therapixelvs
Lunit
Lunit: Lunit covers mammography, tomosynthesis and chest radiography in one portfolio and owns Volpara for density and risk
Therapixel
French mammography AI with FDA clearances for 2D and tomosynthesis breast screening
As of 1 September 2026, Therapixel's pricing is not published; the vendor quotes on request. Therapixel makes MammoScreen, an AI that scores mammographic findings for suspicion on a one to ten scale. Softwr lists it under Healthcare. Therapixel is made by Therapixel SA, available on Web.
Overview
What Therapixel does
Therapixel is a French medical imaging company whose product is MammoScreen, software that automatically detects and characterises soft tissue lesions and calcifications on mammograms and returns a suspicion score from one to ten per finding, plus a study level score. The one to ten scale is deliberate: it is designed to sit alongside a radiologist BI-RADS assessment as a graded signal rather than as a binary positive or negative, which changes how a reader integrates it into a decision. The regulatory history is the fact that decides a purchase. Therapixel received FDA 510(k) clearance K192854 for MammoScreen on two dimensional mammography in July 2020, a second clearance extending it to digital breast tomosynthesis in November 2021, and two further clearances in October 2024 covering later versions. In Europe it is CE marked, but European medical device rules moved from the old Medical Device Directive to the Medical Device Regulation, and diagnostic AI of this class sits at a higher risk classification under MDR with notified body scrutiny to match. European buyers should ask for the current MDR certificate and its expiry, not a legacy CE reference, because a lapsed or transitional certificate is a procurement blocker in public screening programmes. Buyers are breast screening programmes and breast imaging centres, and they are much more concentrated in Europe than in the United States, where Hologic and iCAD have incumbency in the mammography workstation. The trade off is scope: MammoScreen does one thing, mammography, and a hospital wanting AI across head CT, chest and breast will need several vendors and several integrations unless it buys an orchestration layer.
What people use it for
- A European breast screening programme running mandatory double reading that wants to evaluate AI as a concurrent or second reader within what national guidance permits
- An American breast centre that has moved to tomosynthesis and needs reading support on DBT specifically, which Therapixel holds a clearance for
- A screening service wanting a graded suspicion score rather than a binary flag so readers can calibrate their own threshold
- A radiology group evaluating multiple mammography AI vendors head to head on their own historic case set before committing
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The honest half
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 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.
Cross-shopped
What people choose instead of Therapixel
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.
- TherapixelvsAidoc
Aidoc: Aidoc is the choice when the need is acute triage across multiple body regions rather than breast screening
Pricing
What Therapixel costs
Taken from the vendor's own pricing page. Prices move, so check before you buy.
MammoScreen
On request
- 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
- Integration and local validation quoted as professional services
- No published rate card
Capabilities
Features
MammoScreen 2D
Detection and characterisation of soft tissue lesions and calcifications on full field digital mammography
MammoScreen DBT
Cleared extension to digital breast tomosynthesis, which is the reading time problem in most modern breast centres
One to ten suspicion score
Per finding and per study suspicion scores designed to be read as a graded signal alongside BI-RADS rather than as a binary flag
Summary report
A single per study report characterising each finding, intended to be reviewed before or alongside the radiologist read
Workstation and PACS delivery
Results returned into mammography reading workstations and PACS through standard DICOM output
Reading workflow configurations
Supports concurrent reading, second reader and triage configurations depending on what local regulation permits
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 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.
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.
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.
Does it cover anything besides mammography?
No. It is a mammography product only, including tomosynthesis. Other body regions need a different vendor.
Keep looking
Where to go from Therapixel
- Therapixel alternativesEvery product people weigh against it
- Therapixel pricingPlans, floors and what the tiers exclude
- Therapixel badgesWhich rules it meets, and the figure behind each
- All Healthcare softwareThe full category
- Best Healthcare softwareThe shortlist, and how it was cut
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Softwr does not host reviews and shows no star rating for Therapixel, 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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