Vendor source
Reviewed 30 Jun 2026
Completeness Comprehensive (81%)
Volpara Scorecard
Volpara HealthVolpara 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.
Supported by 3 papers
General Information
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Main task
Not specified
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Disease targeted
Regulatory Information
Pathway:
MDD
Class:
Class I
Verified by Health AI Register
Pathway:
510(k) cleared
Class:
Class II
Verified by Health AI Register
Other certifications
Not specified
Evidence & Research
Peer-Reviewed Papers
A comparison of tumour characteristics of screen-detected and interval cancers and their relationship with breast density and AJCC prognostic stage in a UK screening cohort
European Radiology · May 2026
Mammographic density assessment: comparison of radiologists, automated volumetric measurement, and artificial intelligence-based computer-assisted diagnosis
Acta Radiologica · Jun 2024
Supplemental MRI Screening for Women with Extremely Dense Breast Tissue
New England Journal of Medicine · Nov 2019
Technical Papers
Technical Specifications
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Source: Vendor | First published: Jun 9, 2024 | Last updated: Jun 30, 2026