Philips receives FDA clearance to market MicroDose SI mammography system

USA: Royal Philips Electronics announced 510(k) clearance from the Food and Drug Administration (FDA) for its MicroDose SI system, the first full-field digital mammography (FFDM) system on the market with the capability to enable future single-shot spectral imaging applications.

Philips is working on future software applications like Spectral Breast Density Measurement, which will build upon the MicroDose SI technology.

High breast density is a known risk factor for breast cancer—women with high breast density (as seen on a mammogram) are four to five times more likely to get breast cancer than women with low breast density1. Additionally, high breast density features a high proportion of connective tissue, which blocks X-rays, making it difficult for clinicians to interpret breast images.

As a result, categorization of breast density has become mandatory in many countries and several states in the United States.  Unfortunately, there is not yet a standardized method for assessing breast density, which has limited making use of the density categorization for clinical decisions.

The most frequently used method of breast density assessment is subjective manual and visual inspection of the image—different radiologists may give different scoring of breast density for the same image.