Philips Receives FDA Clearance for Spectral Breast Density Measurement Application


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Royal Philips has announced that that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Spectral Breast Density Management Application for its MicroDose SI full-field digital mammography system. The application is the first spectral breast density measurement tool, meaning adipose and glandular tissue can be differentiated to accurately measure volumetric breast density.

The most frequently used methodology to determine breast density is a visual analysis of an image of the breast, but this is often highly subjective and 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.

How It Works

The Spectral Breast Density Measurement Application works by independently measuring 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.

At the recent annual meeting of the Radiological Society of North America (RSNA) in Chicago, Sabee Molloi, MD, Professor of Radiological Sciences, University of California-Irvine School of Medicine, presented data showing 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. The Spectral Breast Density Measurement Application will allow clinicians to comply with this legislation and deliver a more personalized examination to each woman. ■



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