Navigation Links
Philips receives FDA clearance for First-Ever Spectral Breast Density Measurement Application

ANDOVER, Mass., Dec. 19, 2013 /PRNewswire/ -- As breast density becomes a more recognized risk factor for breast cancer, Royal Philips (NYSE: PHG, AEX: PHIA) today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Spectral Breast Density Measurement Application for its MicroDose SI full-field digital mammography (FFDM) system. The application is the first spectral Breast Density Measurement tool, meaning adipose (fat) and glandular tissue can be differentiated to accurately measure volumetric breast density.


Although nearly 50 percent of women have dense breast tissue[i],[ii], a known risk factor for breast cancer[iii], until now, the most frequently used methodology to determine breast density is a visual analysis of an image of the breast. This methodology is highly subjective, meaning several radiologists may allocate a different breast density score for the same image. Rather than estimating density, the Spectral Breast Density Measurement, obtained during a standard, low-dose MicroDose SI mammogram, allows breast density to be objectively measured.

"We strive to make early detection and personalized care a reality for women by helping clinicians refine their risk assessment," says Phil Meyer, Philips General Manager and Vice-President, DXR and Women's Health, North America. "The Spectral Breast Density Measurement Application provides physicians with an objective density measurement, making it easier for them to assess women's breast density and to decide on an appropriate screening program for their profile." 

The Spectral Breast Density Measurement Application works by measuring independently the glandularity and thickness in each pixel of the image to objectively calculate the total volume and volumetric percentage of glandular tissue in the breast. Once the calculations are completed the examination is automatically assigned a MicroDose density score that correlates to the Breast Imaging-Reporting and Data System (BI-RADS), the manual method for determining breast density. The measurement is displayed on the review workstation together in the DICOM tag of the acquired image and exported for display in a DICOM Structured Report.

This first application of non-contrast spectral imaging is made possible by the photon counting technology which sorts photons into low- or high-energy categories, eliminating the need for two exposures. This enables the use of spectral imaging within the routine mammogram and opens up for other future applications that Philips is working on in close collaboration with clinical partners.

At the recent annual meeting of the Radiological Society of North America (RSNA) in Chicago, Sabee Molloi, M.D., professor of radiological sciences, University of California-Irvine School of Medicine, presented data from a reader study including mammography images of 93 women. The results were that spectral mammography may offer quantification of volumetric breast density with excellent precision and could eliminate inter-reader variability in the breast density scoring.

Recent legislation passed in more than a dozen states has made it mandatory for clinicians to report breast density to their patients. [i] The Spectral Breast Density Measurement Application will allow clinicians to comply with this legislation and deliver a more personalized examination to each woman.

For more information on the MicroDose SI mammography system and the Spectral Breast Density Measurement Application, please visit:

For further information, please contact:

Rachel Bloom-Baglin
Philips Healthcare
Tel: +1 978 760 9007

Leslie Lakis
Philips Healthcare
Tel: +978 273 9692

About Royal Philips:
Royal Philips (NYSE: PHG, AEX: PHIA) is a diversified health and well-being company, focused on improving people's lives through meaningful innovation in the areas of Healthcare, Consumer Lifestyle and Lighting. Headquartered in the Netherlands, Philips posted 2012 sales of EUR 24.8 billion and employs approximately 114,000 employees with sales and services in more than 100 countries. The company is a leader in cardiac care, acute care and home healthcare, energy efficient lighting solutions and new lighting applications, as well as male shaving and grooming and oral healthcare. News from Philips is located at

[i] Are You Dense Advocacy, Inc, D.E.N.S.E. Facts, 2011 to 2013.

[ii] Jafi A. Lipson, MD, Jonathan Hargreaves, MD, and Elissa R. Price, MD, on behalf of the California Breast Density Information Group (CBDIG), Frequently Asked Questions About Breast Density, Breast Cancer Risk, and the Breast Density Notification Law in California: A Consensus Document.

[iii] John J. Heine, Christopher G. Scott, Thomas A. Sellers, Kathleen R. Brandt, Daniel J. Serie, Fang-Fang Wu, Marilyn J. Morton, Beth A. Schueler, Fergus J. Couch, Janet E. Olson, V. Shane Pankratz, Celine M. Vachon, A Novel Automated Mammographic Density Measure and Breast Cancer Risk, Oxford University Press: 2012.

SOURCE Royal Philips
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Philips showcases advanced imaging solutions at RSNA 2013
2. Philips highlights its innovative EPIQ ultrasound system and AlluraClarity interventional X-ray system at RSNA 2013
3. Philips unveils breakthrough imaging innovations at RSNA 2013
4. New Study by Imaging the World and Philips Demonstrates the Power of Ultrasound Screenings to Transform Maternal and Newborn Care in Rural Uganda
5. Philips Honored With Prestigious Respiratory Industry Excellence Award At AARC International Respiratory Congress
6. Mercy Teams Up with Philips to Launch Telehealth Services
7. Philips and RealView Imaging conclude worlds first study to evaluate live 3D holographic imaging in interventional cardiology
8. Philips and Infraredx sign agreement for the resale of Infraredxs TVC Imaging System integrated with Philips interventional X-ray systems
9. Philips Showcases Innovations in Radiation Oncology Imaging Technology and Workflow Planning at the 55th American Society for Radiation Oncology (ASTRO) Annual Meeting
10. Philips launches new EPIQ premium ultrasound system with first-of-its-kind nSIGHT technology and Anatomical Intelligence, to address complicated imaging needs of an aging global population
11. Philips bringt neues, hochwertiges Ultraschallsystem EPIQ mit neuartiger nSIGHT-Technologie und Anatomical Intelligence auf den Markt, um den komplizierten Bildgebungsanforderungen einer alternden Weltbevölkerung Rechnung zu tragen
Post Your Comments:
(Date:12/1/2015)... DUBLIN , Dec. 1, 2015 Research ... of the "Global Mouth Ulcer Treatment Market 2015-2019" ... --> --> According to the report, ... of the global population now affected by them. The ... hormonal imbalances, and tobacco smoking. Mouth disorders are also ...
(Date:11/30/2015)... , 1 décembre 2015 ... exposition et conférence d,Asie portant sur ... sur l,industrie manufacturière, se tiendra à ... 20 au 22 avril 2016. ... Photo - ...
(Date:11/30/2015)... , Nov. 30, 2015  QT Vascular Ltd., together ... together with its subsidiaries, TriReme Medical LLC and Quattro ... engaged in the design, assembly and distribution of advanced ... disease, is pleased to announce that a three-judge panel ... of Appeals for the Federal Circuit ("Federal Circuit") has ...
Breaking Medicine Technology:
(Date:12/1/2015)... ... December 01, 2015 , ... ... and SACC-USA through membership and leadership since 2008. Gary Bruce, President of PartnerTech ... . Gary has spent a significant amount of time in Sweden since joining ...
(Date:12/1/2015)... , ... December 01, 2015 , ... ... Center Enterprise Authorized Technology Provider (ATP) status from Cisco. This designation recognizes Tympani ... support Cisco Unified Contact Center solutions targeted to the high-end enterprise contact center ...
(Date:11/30/2015)... ... December 01, 2015 , ... The National ... 2015-2016 inductee into its VIP Woman of the Year Circle. She is recognized ... networking organization exclusively for professional women, boasting 850,000 members and over 200 operating ...
(Date:11/30/2015)... ... November 30, 2015 , ... ... extremely stressful. At the VA Maryland Health Care System, the Caregiver Support ... patients. “Caregivers have a difficult job. Seventy-four percent report that their role ...
(Date:11/30/2015)... ... 30, 2015 , ... Thermi™, a world leader in thermistor-regulated ... ThermiRFR temperature controlled radiofrequency platform has received CE marking and may now be ... temperature as a clinical endpoint. The technology has been available in the ...
Breaking Medicine News(10 mins):