Philips’ breast density measurement application gets FDA clearance

19 December 2013 (Last Updated December 19th, 2013 18:30)

Royal Philips has obtained 510(k) clearance 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.

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Royal Philips has obtained 510(k) clearance 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.

It is reportedly the first spectral breast density tool, meaning fat and glandular tissue can be differentiated to accurately measure volumetric density.

Philips noted that there is not yet a standardised method for assessing density, and different radiologists may score breast density differently in the same image.

In contrast, this spectral breast density tool will help clinicians assess breast density and provide personalised care to patients.

With visual analysis of an image of the breast, the current methodology to determine breast density is highly subjective. The spectral breast density measurement, obtained during a standard, low-dose MicroDose SI mammogram, allows breast density to be objectively measured.

The application works by measuring independently the glandularity and thickness in each pixel of the image to calculate the breast's total volume and volumetric percentage of glandular tissue.

The examination is then automatically assigned a MicroDose density score that correlates to the breast imaging-reporting and data system (BI-RADS), the manual method for determining density.

"The spectral breast density measurement application provides physicians with an objective density measurement."

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.

Philips general manager and vice-president, DXR and women's health North America Phil Meyer said: "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."

Dr Sabee Molloi, professor of radiological sciences, University of California-Irvine School of Medicine recently presented clinical data from a reader study including mammography images of 93 women at Radiological Society of North America (RSNA) 2013 in Chicago.

The results were that spectral mammography may offer quantification of volumetric breast density with excellent precision and could eliminate inter-reader variability in the breast density scoring.


Image: Philips MicroDose mammography. Photo: courtesy of PRNewsFoto/Royal Philips.