The Netherlands-based Royal Philips has obtained 510(k) approval from the US Food and Drug Administration (FDA) for the spectral breast density measurement application for use with its MicroDose SI full-field digital mammography (FFDM) system.
Spectral breast density measurement application available on the MicroDose SI mammography system measures the amount of fibroglandular tissue over the whole breast to objectively determine a volumetric density measurement.
This application differentiates adipose (fat) and glandular tissue for the accurate measurement of volumetric breast density.
The spectral breast density measurement, obtained during a standard, low-dose MicroDose SI mammogram, allows breast density to be objectively measured.
Philips DXR and Women’s Health, North America general manager and vice-president Phil Meyer noted the company strives 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," Meyer added.
Philips’ 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 completing the calculations, the examination is automatically assigned a MicroDose density score that correlates to the Breast Imaging-Reporting and Data System.
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.
According to Philips, this spectral mammography is made possible by the photon counting technology that sorts photons into low- or high-energy categories, eliminating the need for two exposures. This allows the use of spectral imaging within the routine mammogram.
The spectral breast density measurement application will allow clinicians to comply with the recently passed legislation in more than a dozen states that has made it mandatory for clinicians to report breast density to their patients.
Image: Head office of Philips at Amsterdam. Photo: Courtesy of Emilie FH