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:11/26/2015)... Research and Markets ( ) has announced ... Outlook to 2019 - Rise in Cardiac Disorders and Growing ... to their offering. Boston ... scientific and others. --> The market ... Boston scientific and others. ...
(Date:11/26/2015)... Nov. 26, 2015 Research and Markets ... the "2016 Future Horizons and Growth Strategies ... Supplier Shares, Country Segment Forecasts, Competitive Intelligence, Emerging ... --> --> This ... the Japanese therapeutic drug monitoring market, including emerging ...
(Date:11/26/2015)... 2015 ... the  "2016 Future Horizons and Growth ... Testing Market: Supplier Shares, Competitive Intelligence, ... --> ) has ... Future Horizons and Growth Strategies in ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... November 27, 2015 , ... The print component of “Supporting ... Atlanta, Dallas, New York, Minneapolis, South Florida, with a circulation of approximately 250,000 ... through a vast social media strategy and across a network of top news ...
(Date:11/27/2015)... ... ... MPWH, the No.1 Herpes-only dating community in the world, revealed that over 50% of its ... 3.7 billion people under the age of 50 – or 67% of the population - ... estimates of HSV-1 infection . , "The data shocks us highly!" said Michelle Li, ...
(Date:11/27/2015)... Wilmington, DE (PRWEB) , ... November 27, 2015 ... ... a member of the well-respected Microsoft Dynamics SL User Group (MSDSLUG). Recognized as ... is an independent group of Microsoft Dynamics SL software users, partners, industry experts ...
(Date:11/27/2015)... MINNEAPOLIS, Minn. (PRWEB) , ... November 27, 2015 ... ... you start failing. Secura Consultants has prided itself for not only fulfilling the ... best income protection solutions at an affordable price and providing top-tier customer service. ...
(Date:11/27/2015)... Los Angeles, CA (PRWEB) , ... November 27, 2015 , ... ... the Commission on Accreditation of Allied Health Education Programs (CAAHEP) awarded accreditation to its ... exclusive list of CAAHEP accredited colleges, as only one of twelve colleges and universities ...
Breaking Medicine News(10 mins):