News | September 30, 2008

Hologic Receives 510(k) for Breast Density Assessment Tool

September 30, 2008 - Hologic Inc. received FDA 510(k) clearance for the R2 Quantra volumetric breast density assessment tool, a software application for use with Hologic digital mammography systems as an automated method for assessing breast density.
It creates an internal 3D model of the breast from which it derives estimates of the fibroglandular tissue volume and total breast volume; volumetric breast density is the ratio of these values. Using the Quantra tool to provide numeric values for each breast may aid radiologists in the assessment of breast tissue composition without the subjectivity of human interpretation.
According to research published in Journal of the National Cancer Institute, new models for predicting a woman’s risk of developing breast cancer find that breast density is a highly clinically significant predictor of breast cancer risk that is almost as powerful a risk factor as age. Prior to the development of Quantra software, there has not been a consistent breast density assessment method available to clinicians.
“The recent FDA clearance of the Quantra breast density assessment application provides radiologists with a clinical tool to assess breast density and should facilitate better breast cancer risk assessment models for the future,” said Dr. Ronald A. Castellino, Chief Medical Officer for Hologic. “Current clinical breast density assessment methods do not offer a consistent way to assign breast density categories as they tend to focus on human observations of density, rather than numeric measures of density. The Quantra tool should provide researchers with the information they need to conduct further research on breast density’s true relationship with breast cancer.”
The R2 Quantra volumetric breast density assessment application will be available in the U.S. market in October 2008.

For more information: www.hologic.com

Related Content

Sponsored Content | Videos | Breast Imaging | July 28, 2017
Nancy Cappello, Ph.D., executive director and founder of Are You Dense Inc. and Are You Dense Advocacy, explains how
Volpara Solutions to Showcase Volpara Enterprise DDP Software at AHRA 2017
News | Mammography | July 11, 2017
Volpara Solutions Inc. will showcase its new Volpara Enterprise DDP software at the Association for Medical Imaging...
Fujifilm Showcases Digital Radiography, Mammography Innovations at AHRA 2017
News | Digital Radiography (DR) | July 06, 2017
Fujifilm Medical Systems U.S.A. Inc. will present its comprehensive portfolio of digital radiography (DR) and...
Solis Mammography Ranks No. 19 in Dallas Business Journal’s Middle Market 50
News | Mammography | June 30, 2017
June 30, 2017 — Solis Mammography was named the 19th fastest-growing, middle-market company in North Texas by the
GE Healthcare Announces First U.S. Installation of Senographe Pristina Mammography System
News | Mammography | June 29, 2017
GE Healthcare has collaborated with Boca Raton Regional Hospital (Boca Raton, Fla.) to bring a more comfortable...
New Study Highlights Breakthrough Therapy to Reduce Mammographic Breast Density
News | Breast Density | June 28, 2017
Stephen N. Birrell, M.D., Ph.D., presented breakthrough findings into the reduction of mammographic breast density at...
Therapixel Wins the Digital Mammography Challenge
News | Mammography | June 23, 2017
June 23, 2017 — French radiology technology company Therapixel was recently named the winner of the Digital Mammograp
MRI Plus Mammography Improves Detection of New Breast Cancer After Surgery
News | Breast Imaging | June 22, 2017
A new article published by JAMA Oncology compares outcomes for combined mammography and magnetic resonance imaging (MRI...
mammogram

Photo courtesy of Barco

News | Mammography | June 08, 2017
An analysis of breast cancer data revealed that many small breast cancers have an excellent prognosis because they are...
News | Mammography | June 07, 2017
Hologic, Inc. announced that the Genius 3D Mammography exam is now the only mammogram that is FDA-approved as superior...
Overlay Init