MammoScreen

by Therapixel  · Based in France → — AI-Powered Breast Cancer Screening for Radiologists
Radiology
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Subscription (saas model)
Regulatory Status Disclosed

Overview

MammoScreen by Therapixel is an advanced Artificial Intelligence (AI) software designed to assist radiologists in breast cancer screening. Utilizing deep learning technologies, MammoScreen analyzes both 2D Full Field Digital Mammography (FFDM) and 3D Digital Breast Tomosynthesis (DBT) images to detect and characterize suspicious soft tissue lesions and calcifications.

The software provides an actionable MammoScreen Score™, grading each lesion on a scale of 1 to 10 to indicate the likelihood of malignancy, thereby offering quick and reliable confirmation for radiologists. It functions as a concurrent reading aid, aiming to improve radiologists’ cancer detection rates, reduce false positives, and decrease reading time, ultimately enhancing diagnostic confidence and workflow efficiency.

MammoScreen is designed for seamless integration into existing radiology workflows, compatible with PACS and RIS systems, and can leverage prior mammograms for even greater accuracy by analyzing temporal changes. Therapixel, a French company founded in 2013, specializes in AI for medical imaging and is committed to delivering pertinent information to healthcare professionals to improve women’s health.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-based breast cancer screening software
  • Detects and characterizes suspicious soft tissue lesions and calcifications
  • MammoScreen Scoreu2122 (1-10 likelihood of malignancy)
  • Supports Digital Breast Tomosynthesis (3D Mammography) and Full Field Digital Mammography (2D)
  • Concurrent reading aid for interpreting physicians
  • Improves radiologists' cancer detection rate and reduces false positives
  • Reduces reading time and enhances workflow efficiency
  • Leverages prior mammograms for improved accuracy and temporal change analysis
  • Explainable AI with linked characterization of malignancy
  • Breast density assessment feature

Use Cases

  • Assisting radiologists in breast cancer screening
  • Improving cancer detection accuracy and reducing missed cancers
  • Reducing radiologist workload and fatigue during interpretation
  • Enhancing diagnostic confidence for both low and high suspicion cases
  • Streamlining workflow in mammography interpretation
  • Identifying findings on screening FFDM and DBT

What Physicians Need to Know

Key Capabilities
MammoScreen is an AI-powered software that aids in identifying and characterizing suspicious findings (calcifications, soft tissue lesions, architectural distortions, masses, asymmetries) in 2D FFDM and 3D DBT mammograms. It provides an actionable MammoScreen Score (1-10 scale) for each finding, breast, and overall case, indicating the level of suspicion. The tool incorporates prior mammograms to analyze temporal changes, offers worklist management with a complexity index, includes a case pre-check for image quality and patient history, provides breast density assessment, and features a pre-reporting function to generate draft reports.
Clinical Utility
The tool improves radiologists' diagnostic performance by increasing sensitivity (e.g., up to 8 percentage points) and specificity (e.g., up to 6 percentage points), and reducing false-negative rates (up to 47%) and false-positive rates. It has been shown to reduce reading time (up to 35%) and inter-reader variability, while increasing reader confidence (up to 53%). MammoScreen also helps lower unnecessary recalls and reduces radiologist fatigue by 40%. It can detect 42% of cancers one year prior and 38.5% two years prior to diagnosis.
Integration Options
MammoScreen is a software-only, vendor-neutral device designed for a zero-click workflow. It is configured as a DICOM Web compliant node and supports DICOM-SR and DICOM-SC. Installation can be cloud-based or on-premise, with deployment described as simple and achievable remotely within hours. It integrates seamlessly with existing PACS platforms, such as RamSoft's PowerServer and OmegaAI, and can be combined with other AI solutions like CureMetrix's cmAngio.
Compliance Status
MammoScreen is FDA 510(k) cleared for FFDM (2D) and DBT (3D) mammograms (e.g., K211541) and holds CE marking for sale in the EU. It is HIPAA compliant, utilizing a HIPAA-compliant cloud host, and ensures data privacy by de-identifying DICOM images and deleting them from the cloud after processing. Non-clinical testing adheres to standards like IEC 62304 and IEC 62366-1.
Pricing Model
The product is offered through a Software as a Service (SaaS) model, where customers pay only for the number of mammograms successfully processed. This model ensures access to the latest software versions without additional charges and allows for seamless scalability.
User Experience
MammoScreen features an intuitive and actionable 1-10 scoring system, often presented with a green/yellow/red color scheme. It is designed to reduce the 'trauma' of excessive CAD marks by initially displaying only the most suspicious findings. The 'zero-click workflow' and pre-reporting feature streamline radiologist tasks, while worklist management with a complexity index helps prioritize cases, contributing to reduced radiologist fatigue.
Support Quality
Therapixel is committed to improving women's health and actively seeks feedback. The company offers demos and pilot programs for potential users to test the software. Contact information is readily available for inquiries.
Implementation Complexity
Described as one of the simplest installations for IT professionals, MammoScreen can be deployed remotely and installed within hours. It is a single, integrated software solution, reducing the workload associated with managing multiple AI systems.
Evidence Base
MammoScreen was the winner of the Digital Mammography DREAM Challenge in 2017. It has been trained on extensive databases of biopsy-proven breast cancer cases from the US and Europe. Multiple multi-reader, multi-case retrospective studies, published in journals like Radiology: Artificial Intelligence, demonstrate its effectiveness in improving radiologist performance, including increased AUC, sensitivity, specificity, and reduced false positives/negatives and reading times. The use of 2D, 3D, and prior images has been evaluated for enhanced performance, with findings presented at major conferences such as RSNA and SBI.
Physician Tip

Leverage MammoScreen's actionable 1-10 scoring system and worklist complexity index to prioritize and focus on higher-suspicion cases, potentially reducing reading time and fatigue. Utilize the pre-reporting feature to streamline documentation. Pay attention to the AI's insights on temporal changes from prior exams, as this can significantly enhance early detection. Remember that MammoScreen is a concurrent reading aid; clinical decisions should always integrate the radiologist's expert interpretation and not solely rely on the AI's output. The breast density assessment and case pre-check features can further support comprehensive patient evaluation.

MammoScreen offers flexible integration as a DICOM Web compliant node, supporting both cloud-based and on-premise deployments. Its vendor-neutral, zero-click workflow is designed for minimal IT overhead and seamless integration into existing PACS environments. The ability to integrate with other AI solutions, such as for breast arterial calcification detection, allows for a more comprehensive AI-powered breast imaging suite. Discuss specific DICOM-SR/SC requirements and workflow customization options with Therapixel to ensure optimal setup within your current infrastructure.

Details

Category Oncology AI, Radiology & Imaging AI
Pricing Subscription (saas model) — Pay per mammogram successfully processed; includes latest software versions and scalable usage.
DeploymentSaaS (Software as a Service) model with fully-remote installation. Utilizes a virtual local server on-site that sends de-identified and encrypted data to a HIPAA-compliant cloud for processing, with AI reports returned and stored within the local network.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Yes AI-estimated

MammoScreen received its initial 510(k) clearance (K192854) from the U.S. FDA in May 2020 for Full Field Digital Mammography (2D). A second 510(k) clearance (K211541) was granted on November 26, 2021, expanding its use to Digital Breast Tomosynthesis (3D Mammography).
Integrations
EHR Not specified
Specialties Radiology

What the Web Says

MammoScreen is an AI-powered software designed to assist radiologists in breast cancer screening by providing a second assessment of mammograms. It aims to improve detection rates, reduce false negatives, and enhance workflow efficiency for radiologists. The system has received FDA clearance for both 2D and 3D mammography and can also assess breast density and predict 5-year breast cancer risk.

Overall: Positive

Strengths

  • Improves diagnostic performance and accuracy in breast cancer detection, with studies showing increased sensitivity and specificity for radiologists using the tool.
  • Reduces radiologist workload and fatigue, potentially preventing burnout, and can decrease reading time, especially for cases with a low likelihood of malignancy.
  • Identifies subtle lesions that might be missed by human eyes, and in some cases, has detected cancer earlier than unassisted radiologists.
  • Incorporates prior mammograms into its analysis, allowing it to detect temporal changes and improve confidence in assessments.
  • Offers a comprehensive suite of features including worklist management, case pre-check, density assessment, and pre-reporting, streamlining the screening workflow.
  • Provides an intuitive and actionable scoring system for suspicious findings, helping radiologists prioritize and focus on complex cases.

Limitations

  • Some Reddit users express skepticism about paying an additional fee for AI services, questioning if it's a money grab or should be covered by standard mammograms.
  • One study noted a limitation where the dataset used was not representative of normal screening practices, potentially leading to a higher rate of false-positive readings due to readers' awareness of cancer-enriched cases.
  • The AI tool for breast density assessment is not a diagnostic software and patient management decisions should not be made solely based on its analysis.
  • There isn't a clear playbook for AI deployment in mammography, and with many FDA-approved tools available, selecting the right one can be challenging for practices.
  • The technology is still evolving, and while promising, some users may be hesitant to fully embrace it without more widespread information and integration into standard practices.

Based on reviews from: Therapixel.com, Ferrum Health, CancerNetwork, AuntMinnie.com, FDA.gov, Reddit, YouTube (WISH-TV), Applied Radiology, UDS - United Diagnostic Services

Last updated: 2026-07-20

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Press & Coverage

Imaging Technology News
Therapixel Releases A New Version Of MammoScreen - Imaging Technology News
Therapixel has released a new version of MammoScreen (2D and 3D) that incorporates prior mammograms into its analysis, improving performance by detecting changes over time. The system assigns a MammoScreen Score from 1-10 to lesions, with higher scores indicating greater suspicion.
2022-05
The MammoScreen Project
Developing AI for early breast cancer detection - The MammoScreen Project
The MammoScreen Project is focused on enhancing the AI-driven algorithm within MammoWaveu00ae technology to detect early-stage breast cancer while minimizing false results. This involves an iterative process of data acquisition, algorithm improvement, and rigorous clinical validation.
2025-06
Therapixel
MammoScreen Cleared for Tomo Readings
Therapixel announced that MammoScreen received a second 510(k) clearance from the FDA, expanding its use to Digital Breast Tomosynthesis (3D Mammography). This clearance allows MammoScreen to assist radiologists in both 2D and 3D mammography, aiming for more efficient workflow and reduced costs.
2025-10
Therapixel
Meet the New MammoScreen
Therapixel announced FDA clearance for its new generation of MammoScreen, which includes new features like worklist management, case pre-check, and breast density assessment. This updated AI aims to make breast cancer screening more efficient and accurate for radiologists.
2024-10
Therapixel
MammoScreenu00ae Breast AI Adopted by Mayo Clinic for Radiology Use
Mayo Clinic has licensed MammoScreen for use across its radiology departments, integrating the AI-based breast cancer screening software into its clinical workflow. This adoption follows Therapixel's participation in the Mayo Clinic and Arizona State University Alliance for Health Care's MedTech Accelerator Program.
2025-05
AuntMinnieEurope
Therapixel gets CE Mark for MammoScreen software - AuntMinnieEurope
Therapixel received the CE Mark for its MammoScreen software, enabling its sale in the European Union. The software, which analyzes mammography images and provides a malignancy probability score, had previously received U.S. FDA clearance in March 2020.
2021-01
CancerNetwork
MammoScreen AI Tool Improves Diagnostic Performance of Radiologists in Detecting Breast Cancer | CancerNetwork
A clinical investigation published in Radiology: Artificial Intelligence demonstrated that MammoScreen improved radiologists' diagnostic performance in breast cancer detection without prolonging workflow. The AI tool identifies suspicious regions on 2D digital mammograms and assigns a likelihood of malignancy score.
2020-12
BioSpace
Therapixel Announces Two New FDA Clearances for its Most Advanced Breast Cancer Screening AI Solution - BioSpace
Therapixel received two new FDA 510(k) clearances for MammoScreen, releasing its most comprehensive breast cancer screening AI solution. The updated software includes features like worklist management, case pre-check, screening assessment with priors, breast density assessment, and pre-reporting.
2024-10

Videos

Product demos, reviews, and walkthroughs for MammoScreen.

View all on YouTube

Frequently Asked Questions

MammoScreen is an AI tool designed to assist radiologists in reading both 2D and 3D screening mammograms by identifying suspicious regions and characterizing them with a malignancy score. It aims to improve diagnostic performance, increase sensitivity, and enhance efficiency, while also reducing false negatives and inter-reader variability.
MammoScreen has received FDA clearance for use in both 2D Full Field Digital Mammography (FFDM) and 3D Digital Breast Tomosynthesis (DBT), and it also holds CE marking for the European Union. Furthermore, Therapixel, the developer, states that MammoScreen is ISO 27001 Certified and HIPAA Compliant, ensuring patient data privacy and security.
Yes, other AI-powered mammography solutions exist in the market, such as Transpara, Lunit INSIGHT MMG, and Saige-Q. Additionally, emerging technologies like panoramic photoacoustic computed tomography (PACT) are being explored as non-invasive alternatives to traditional mammography, ultrasound, and MRI for breast cancer screening.
MammoScreen is typically offered through a Software as a Service (SaaS) subscription model, where healthcare facilities pay based on the volume of mammograms processed. This operational expenditure model eliminates the need for large upfront capital investments and includes ongoing software updates and technical support.
Initial studies on MammoScreen had limitations, such as datasets that were not fully representative of normal screening populations and a lack of access to prior patient information. General concerns with AI in radiology include potential biases from limited data diversity in training sets, challenges in integrating with existing PACS systems, and the fact that AI is an assistive tool and cannot replace the comprehensive judgment and experience of a radiologist.
MammoScreen ensures data privacy and security by de-identifying and encrypting mammography studies before they are sent to its cloud for processing, with no patient-identifiable information leaving the facility. The system is ISO 27001 Certified and HIPAA Compliant, and it integrates with existing PACS and EMR systems using secure protocols like HL7 or FHIR.
Yes, MammoScreen is designed for seamless integration into existing radiology workflows and PACS systems. It can be deployed via a virtual gateway within the facility, and reports can be sent back and integrated into screening software through various methods like a widget, DICOM SR, or DICOM SC.

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19
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