MedAI Verdict
Radiology

AI Radiology

Therapixel MammoScreen

by Therapixel  ·  FR

Last verified

MammoScreen: breast cancer detection and density AI for 2D mammograms and tomosynthesis.

At a glance

Pricing
No public price. Enterprise sale.
HIPAA
Not disclosed
SOC 2
Not disclosed
EHRs
—
Founded
—
HQ
FR
On this page

Independent score  ·  By our public rubric

21/100Niche fit
How it’s computed →
  • Regulatory & Compliance
    18/28

    FDA cleared (7 K-numbers on record)

  • 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 clearance18/18

    FDA cleared (7 K-numbers on record)

  • 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

MammoScreen: breast cancer detection and density AI for 2D mammograms and tomosynthesis.

No public price. Enterprise sale.

Editorial review  ·  By MedAI Verdict

Bottom line

MammoScreen is breast cancer screening software from Therapixel of Nice, France. It reads 2D mammograms and tomosynthesis and has seven FDA 510(k) clearances since 2020, plus a CE mark. Breast imaging practices and health systems buy it, and the price is by quote only.

Who is Therapixel?

Therapixel calls itself one of the leading French software companies specializing in artificial intelligence applied to medical imaging. It says the software "helps in reading digital mammograms to detect and qualify suspicious tissue" and was trained by deep learning on "hundreds of thousands of cases" annotated by breast radiologists and confirmed by biopsy. A companion product, MammoScreen BD, assesses breast density.

Therapixel is at 455 Promenade des Anglais in Nice. Pierre Fillard and Olivier Clatz founded it in 2013, according to Tracxn. Total funding is about $22 million to $23 million (Tracxn $22.1 million, CB Insights $23.13 million), including a EUR 15 million Series B in May 2022. Investors listed on its site include Creazur, IT Translation, Omnes, M Capital and Region Sud Investissement.

Which FDA clearances does it hold?

The vendor says MammoScreen is "FDA-cleared and CE-marked", with CE 0297 class IIa and ISO 13485. FDA's 510(k) records list seven clearances for Therapixel, with these decision dates:

  • K192854, March 2020, MammoScreen
  • K211541, November 2021, MammoScreen 2.0
  • K240301, August 2024, MammoScreen (3)
  • K241561, October 2024, MammoScreen BD
  • K243679, July 2025, MammoScreen (4)
  • K243685, August 2025, MammoScreen BD
  • K260714, June 2026, MammoScreen (5)

Where is it in use?

Mayo Clinic selected MammoScreen in June 2025. In April 2025 Onsite Women's Health announced plans to deploy it across more than 150 locations.

What studies are public?

Tracxn mentions the 2017 DREAM Challenge for mammography. In October 2022 Therapixel announced a prospective French study on the use of AI in second reading of screening mammograms.

How is it priced?

Therapixel sells to enterprise buyers and gives no public price.

The verdict

MammoScreen has a clearance record that spans six years and five software versions, plus deployments at Mayo Clinic and across Onsite's network. A breast imaging practice or health system that reads screening mammograms is the buyer. A practice that does not read mammograms has nothing to buy.

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
Enterprise——No public price. Enterprise sale.

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

Compliance + integration

What deploys cleanly

Carries FDA 510(k), CE Mark (Class IIa, CE 0297, vendor-stated), ISO 13485 (vendor-stated) per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.