Philips (NYSE:PHG) said it landed 510(k) clearance for its spectral breast density measurement application, a new feature for its MicroDose SI full-field digital mammography system.
The application allows for adipose and glandular tissue to be differentiated to accurately measure volumetric breast density, a new step in tracking and detection of breast cancer. Dense breast tissue is a known risk factor for breast cancer and is commonly indicated by a visual analysis of an image of the breast.
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. After the calculations are completed, the examination is automatically assigned a MicroDose density score that correlates to the Breast Imaging-Reporting and Data System, the manual method for determining breast density.
“We strive to make early detection and personalized care a reality for women by helping clinicians refine their risk assessment. 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,” North America General Manager & Vice-President of DXR & Women’s Health Phil Meyer said in prepared remarks.