Key Features

  • Lesion detection and characterization
  • Level-of-suspicion score

General Information

Product name

MammoScreen®

Company

Subspeciality

Breast

Modality

Mammography

Disease targeted

Breast cancer

Main task

Not specified

Technical Specifications

Population

Screening mammography

Patient population age

Not specified

Input

Screening DBT & FFDM, prior images if available

Input format

DICOM

Output

Visual report with detected and assessed lesions

Output format

Web interface or DICOM SC or DICOM SR.

Integration

Integration via AI marketplace or distribution platform, Stand-alone webbased

Deployment

Cloud-based

Trigger for analysis

Automatically, Right after the image acquisition

Processing time

Not specified

Regulatory Information

CE Certification

Pathway:

MDD

Class:

Class IIa

Verified by Health AI Register
FDA Certification

Pathway:

510(k) cleared

Class:

Class II

Verified by Health AI Register

Other certifications

Not specified

Market Presence

On market since

FFDM FDA 05-2020_x000D_ FFDM CE 12-2020_x000D_ DBT CE 11-2021_x000D_ DBT FDA 11-2021

AI Platforms

Ferrum Health, Incepto, Softway Medical, Tempus

Resellers

Milvue, Osimis, Qure.ai

Countries present

Not specified

Paying clinical customers

Not specified

Research/test users

Not specified

Pricing Information

Pricing model

Subscription

Based on

Not specified

Evidence & Research

Peer-Reviewed Papers

Peer-Reviewed

View

Evaluation of Combined Artificial Intelligence and Radiologist Assessment to Interpret Screening Mammograms

Peer-Reviewed

View

Improving Breast Cancer Detection Accuracy of Mammography with the Concurrent Use of an Artificial Intelligence Tool

Technical Papers

Technical

View

Breast screening and artificial intelligence: an independent evaluation of two different software carried out at Valenciennes hospital

Other Articles

Other

View

Comparison of Mammography AI Algorithms with a Clinical Risk Model for 5-year Breast Cancer Risk Prediction: An Observational Study

Source: vendor | First published: Jun 20, 2023 | Last updated: Jul 9, 2025