VolparaDensity

Volpara Health

Volpara is a software application intended for use with digital breast x-ray systems, including tomosynthesis. Volpara calculates and quantifies volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates. Volpara provides these numerical values along with a BI-RADS breast density 4th or 5th Edition category to aid health care professionals in the assessment of breast tissue composition.

Information source: Vendor
Last updated: May 24, 2023

General Information

General
Product name	VolparaDensity
Company	Volpara Health
Subspeciality	Breast
Modality	Mammography
Disease targeted	Breast cancer
Key-features	Breast density quantification, BI-RADS, BI-RADS breast density category
Suggested use	After: diagnosis verification

Technical Specifications

Data characteristics
Population	Breast screening population
Input	2D Full-Field Digital Mammography, 3D Digital Breast Tomosynthesis
Input format	DICOM
Output	DICOM structured report
Output format	DICOM
Technology
Integration	Integration in standard reading environment (PACS), Integration RIS (Radiological Information System)
Deployment	Locally on dedicated hardware, Locally virtualized (virtual machine, docker), Cloud-based
Trigger for analysis	Automatically, right after the image acquisition
Processing time	10 - 60 seconds

Regulatory

Certification
CE	Certified, Class I , MDD
FDA	510(k) cleared , Class II
Intended Use Statements
Intended use (according to CE)	VolparaDensity is a software application intended for use with the raw data from digital breast x-ray systems, including tomosynthesis. VolparaDensity calculates and quantifies a density map and from that determines volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates. VolparaDensity provides these numerical values along with a BI-RADS breast density 4th or 5th Edition category to aid health care professionals in the assessment of breast composition. VolparaDensity is not an interpretive or diagnostic aid and should be used only as adjunctive information when the final assessment of breast density category is made by an MQSA-qualified interpreting physician.

Market

Market presence
On market since	10-2010
Distribution channels
Countries present (clinical, non-research use)	36
Paying clinical customers (institutes)
Research/test users (institutes)
Pricing
Pricing model	Pay-per-use, Subscription, One-off payment
Based on	Number of users, Number of installations, Number of analyses

Evidence

Evidence
Peer reviewed papers on performance	Supplemental MRI Screening for Women with Extremely Dense Breast Tissue (read)
Non-peer reviewed papers on performance	Impact of Artificial Intelligence System and Volumetric Density on Risk Prediction of Interval, Screen-Detected, and Advanced Breast Cancer (read) A Case-Control Study to Add Volumetric or Clinical Mammographic Density into the Tyrer-Cuzick Breast Cancer Risk Model (read)
Other relevant papers	Digital mammographic density and breast cancer risk: a case–control study of six alternative density assessment methods (read)