First Spectral Breast Density Test Earns FDA Sign-Off

Royal Philips has received clearance from the Food and Drug Administration for a new tool to objectively measure breast density, a known risk factor for breast cancer. The Spectral Breast Density Application runs on the company’s MicroDose SI full-field digital mammography (FFDM) system and is the first spectral tool to differentiate between adipose and glandular tissue.

Previous assessments of breast density have relied on a subjective analysis based on a visual image of the breast. The Spectral Breast Density application uses photon-counting technology to sort photons into high- and low-energy categories and capture additional data during a routine mammogram. The software analyzes pixels in the captured image to measure total volume and volumetric percentage of glandular tissue, then assigns a MicroDose density score based on the Breast Imaging-Reporting and Data System (BI-RADS) standards. The information is exported in a DICOM structured report.

For more information, visit Philips.