MammoScreen®

Therapixel

MammoScreen helps radiologists to identify findings on screening mammograms and assess their level of suspicion. MammoScreen® uses a color coded MammoScreen Score™ to provide an at a glance level-of-suspicion scoring for screening mammograms; confirming the lowest and highest scores (the green and red cases, respectively for the lowest and highest suspicion categories), and emphasizing those that require deeper scrutiny (the yellow cases, for the indeterminate category).

Information source: Vendor
Last updated: June 20, 2023

General Information

General
Product name	MammoScreen®
Company	Therapixel
Subspeciality	Breast
Modality	Mammography
Disease targeted	Breast cancer
Key-features	Lesion detection and characterization, level-of-suspicion score
Suggested use	During: perception aid (prompting all abnormalities/results/heatmaps)

Technical Specifications

Data characteristics
Population	Screening mammography
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.
Technology
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

Regulatory

Certification
CE	Certified, Class IIa , MDD
FDA	510(k) cleared , Class II
Intended Use Statements
Intended use (according to CE)	MammoScreen™ is intended for use as a concurrent reading aid for physicians interpreting screening mammograms, to identify regions suspicious for breast cancer and assess their likelihood of malignancy. Output of the device includes marks placed on abnormal regions of the mammogram and likelihood of malignancy scores. The abnormal regions could be soft tissue lesions or calcifications. The likelihood of malignancy score is expressed at the abnormal area level, for each breast and overall for the mammogram. Patient management decisions should not be made solely on the basis of analysis by MammoScreen™.

Market

Market presence
On market since	FFDM FDA 05-2020 FFDM CE 12-2020 DBT CE 11-2021 DBT FDA 11-2021
Distribution channels	Ferrum Health, Softway Medical, Osimis, Qure.ai, Tempus Pixel
Countries present (clinical, non-research use)
Paying clinical customers (institutes)
Research/test users (institutes)
Pricing
Pricing model	Subscription
Based on

Evidence

Evidence
Peer reviewed papers on performance	Evaluation of Combined Artificial Intelligence and Radiologist Assessment to Interpret Screening Mammograms (read) Improving Breast Cancer Detection Accuracy of Mammography with the Concurrent Use of an Artificial Intelligence Tool (read)
Non-peer reviewed papers on performance	Breast screening and artificial intelligence: an independent evaluation of two different software carried out at Valenciennes hospital (read)
Other relevant papers	Comparison of Mammography AI Algorithms with a Clinical Risk Model for 5-year Breast Cancer Risk Prediction: An Observational Study (read)