Visage Breast Density

Visage Imaging, Inc.
**Only available with Visage 7 Enterprise Imaging Platform and Hologic equipment**
Visage Breast Density is a software application intended for use with compatible full field digital mammography and digital breast tomosynthesis systems. Visage Breast Density assesses breast density from a mammography study and provides an ACR BI-RADS Atlas 5th Edition breast density category to aid radiologists in the assessment of breast tissue composition. Visage Breast Density produces adjunctive information. It is not a diagnostic aid. Visage Breast Density is based on the Visage 7 Enterprise Imaging Platform for distributing, viewing, processing, and archiving medical images. AI inference is calculated automatically upon study ingest into PACS so that results are available upon study open.
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Information source: Vendor
Last updated: July 19, 2023

General Information

General
Product name Visage Breast Density
Company Visage Imaging, Inc.
Subspeciality Breast
Modality Mammography
Disease targeted Breast cancer
Key-features Breast density classification
Suggested use During: perception aid (prompting all abnormalities/results/heatmaps), interactive decision support (shows abnormalities/results only on demand), report suggestion

Technical Specifications

Data characteristics
Population Intended for symptomatic and asymptomatic female adults
Input Full Field Digital Mammograms or C-View images (i.e. synthetic mammograms created from tomosynthesis data sets) from Hologic.
Input format DICOM
Output Breast density classification (adjustable by radiologist), confidence score. Integration with reporting software via Visage 7 possible.
Output format
Technology
Integration Integration in standard reading environment (PACS)
Deployment Locally virtualized (virtual machine, docker), Cloud-based
Trigger for analysis Automatically, right after the image acquisition, On demand, triggered by a user through e.g. a button click, image upload, etc.
Processing time < 3 sec

Regulatory

Certification
CE
Certified, Class IIa , MDD
FDA 510(k) cleared , Class II
Intended Use Statements
Intended use (according to CE) Visage Breast Density is a software application intended for use with compatible full field digital mammography and digital breast tomosynthesis systems. Visage Breast Density assesses breast density from a mammography study and provides an ACR BI-RADS Atlas 5th Edition breast density category to aid radiologists in the assessment of breast tissue composition. Visage Breast Density produces adjunctive information. It is not a diagnostic aid. Visage Breast Density is based on the Visage 7 product for distributing, viewing, processing, and archiving medical images.

Market

Market presence
On market since EU: 05/2020, USA: 01/ 2021, CAN: 07/2020, AUS: 07/2020
Distribution channels
Countries present (clinical, non-research use) 4 countries / areas (EU)
Paying clinical customers (institutes)
Research/test users (institutes) 2
Pricing
Pricing model
Based on

Evidence

Evidence
Peer reviewed papers on performance

  • PACS-integrated machine learning breast density classifier: clinical validation (read)
Non-peer reviewed papers on performance
Other relevant papers