Visage Breast Density

Visage Imaging, Inc.

**Only available with Visage 7 PACS 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 product 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.
Product specifications Information source: Vendor
Last updated: July 11, 2022
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
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
Certification
CE
Certified, Class IIa , MDD
FDA
510(k) cleared, Class II
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) 1
Research/test users (institutes) 2
Pricing
Pricing model
Based on
Evidence
Peer reviewed papers on performance
Non-peer reviewed papers on performance
Other relevant papers