Technology | Breast Density | November 12, 2015

FDA Clears VolparaDensity 3.1 Breast Density Assessment With ACR BI-RADS 5th Edition

Company will demonstrate latest version of breast density assessment software, other advances to quantitative breast imaging suite at RSNA 2015

VolparaDensity 3.1, breast density assessment, FDA approval, BI-RADS Fifth Edition, RSNA 2015

Image courtesy of Volpara Solutions

November 12, 2015 — Volpara Solutions announced that it has received a new 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its VolparaDensity breast imaging software.

Originally cleared for use by the FDA in 2010, the new clearance covers VolparaDensity version 3.1, which has been specifically designed to correlate to the new Fifth Edition of the Breast Imaging-Reporting and Data System (BI-RADS) Atlas recently issued by the American College of Radiology (ACR). The 5th Edition Atlas was updated to require “an overall assessment of the volume of attenuating tissues in the breast, to help indicate the relative possibility that a lesion could be obscured … and that the sensitivity of examination thereby may be compromised by dense breast tissue.” Development of Volpara’s new software included a reader study which was used to optimize VolparaDensity performance to the BI-RADS 5th Edition.

Volpara will showcase VolparaDensity 3.1 software and other new advances to its suite of quantitative breast imaging tools at the 2015 Radiology Society of North America (RSNA) meeting, Nov. 29-Dec. in Chicago.

Because of its volumetric approach, VolparaDensity goes beyond measurement of dense tissue area, and actually measures the compressed thickness and volume of dense tissue to truly show when small regions of “focal density” present a masking risk. VolparaDensity results have been clinically validated in independent studies to correlate to mammography sensitivity.

Volpara has also developed a detailed discussion of the changes that have been made to VolparaDensity to reflect the new ACR BI-RADS Atlas 5th Edition, including significant input from the Volpara customer base, study of the literature, reader study results and research using in-house Volpara databases.

Breast density has not only been linked to an increased risk of breast cancer, it also dramatically impacts early detection. Several large studies have confirmed that as density increases the accuracy of mammography decreases. According to a study published in the New England Journal of Medicine, 35 percent of breast cancer goes undetected by mammography in women with dense breasts and density masks appearance of tumors. Since both dense breast tissue and cancer appear white on a mammogram, it is analogous to looking for a snowball in a snow storm.

Cleared by the FDA, HealthCanada, the TGA and CE-marked, VolparaDensity helps radiologists objectively assess density from digital mammography and tomosynthesis images to determine which women might benefit from additional imaging. Highly correlated to breast magnetic resonance (MR) assessments, VolparaDensity automatically generates an objective measurement of volumetric breast density correlated to the American College of Radiology (ACR) BI-RADS breast density categories.

For more information: www.volparasolutions.com

Related Content

Keith Dreyer, DO, said artificial intelligence is one of the most important developments to watch in radiology at the opening session of RSNA 2016.

Keith Dreyer, DO,  said artificial intelligence is one of the most important developments to watch in radiology at the opening session of RSNA 2016.

Feature | Artificial Intelligence | November 17, 2017
November 16, 2017 — The American College of Radiology Data Science Institute (DSI) will provide the framework, strate
Biop Medical Launches Cervical Cancer Diagnosis Technology at MEDICA 2017

Biop Medical cervical cancer detection system

Technology | Women's Health | November 13, 2017
November 13, 2017 — Biop Medical announced it will present its point-of-care...
Kansas City Radiology Center Employs iCAD PowerLook Tomo Detection for DBT
News | Computer-Aided Detection Software | November 10, 2017
November 10, 2017 — Imaging for Women, a leading radiology center in Kansas City, Mo., announced it is now using iCAD
Kubtec Brings Image Analytics Capabilities to Tomosynthesis Specimen Imaging Systems
News | Mammography | November 10, 2017
Kubtec announced it will be showcasing new image analytics capabilities on its advanced tomosynthesis specimen imaging...
Siemens Healthineers Introduces Share360 Tailored Service Portfolio
News | Imaging | November 10, 2017
November 10, 2017 — To address the specific needs of...
Fujifilm Highlights Women's Health and Pediatrics at RSNA 2017
News | Information Technology | November 08, 2017
November 8, 2017 — Fujifilm Healthcare will showcase a variety of imaging and information technology solutions at the
CureMetrix Expands Medical Advisory Board
News | Computer-Aided Detection Software | November 08, 2017
November 8, 2017 — CureMetrix, a company developing...
ICPME Makes EQUIP Mammography Inspection CME/CE Webinar Available Online
News | Mammography | November 08, 2017
November 8, 2017 — In conjunction with Brea...
Study Suggests Breast Cancer Patients Forego Post-Surgery Treatment Due to Mistrust
News | Radiation Therapy | November 06, 2017
November 6, 2017 — Nearly one-third of women with...
Study shows tissue marker reduces radiation target volumes, produces many other advantages

These CT images show placement of a 3-D fixed array implanted fiducial (3-D marker) at the time of oncoplastic tumor resection. The original LCTV (LCTVo) was retrospectively re-contoured by the radiation oncologist (LCTVro) and breast surgeon (LCTVbs). Thereafter, both re-contours were combined to create the collaborative LCTV (LCTVc), which required agreement of both the radiation oncologist and breast surgeon. Volume differences between the original LCTV (LCTVo) and the collaborative LCTVc were then evaluated, and demonstrated a mean and median reduction in LCTV.

Feature | Tumor Tracking Systems | November 06, 2017 | By William Hall, M.D.
Radiation planning for breast cancer relies on accurate delineation of the post-lumpectomy target volume as identified...
Overlay Init