FDA Clears Philips’ Breast Density Measurement Application

Philips received FDA clearance for the first spectral breast density measurement application.

The application is for use with Philips’ MicroDose SI full-field digital mammography system. It’s the first spectral breast density tool, meaning fat and glandular tissue can be differentiated to accurately measure volumentric density, according to the company.

The most frequently used method to determine breast density is a visual analysis of an image of the breast. The spectral breast density measurement allows a more objective measurement, according to the company.

The application works by measuring independently the glandularity and thickness in each pixel of the image to calculate the total volume and volumetric percentage of glandular tissue in the breast. The examination is then automatically assigned a MicroDose density score that correlates to BI-RADS, the manual method for determining density.

Philips’ spectral mammography is made possible by the photon counting technology that sorts photos into low- or high-energy categories, eliminating the need for two exposures, the company said. This allows for spectral imaging within the routine mammogram.


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