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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.

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