VuComp said it won 510(k) clearance from the FDA for its M-Vu breast density tool, which provides automated assessment of breast density from a digital mammogram.
The M-Vu uses advanced computer vision algorithms to evaluate the appearance of structures and textures in the breast to differentiate between fatty and dense regions. It then calculates a percentage of breast area that is dense, translating it to 1 of 4 density categories corresponding to the BI-RADS standard.
The Plano, Texas-based company said the device is now available and can be combined with VuComp’s computer-aided detection system, M-Vu CAD, to “provide a comprehensive set of high-performance analysis tools for mammography,” according to a press release.
“We believe that M-Vu Breast Density will become an important new technology for greater objectivity and consistency in breast density assessment. In contrast to the volumetric approach, we designed M-Vu Breast Density to analyze the appearance of fibroglandular tissue rather than simply the total amount of such tissue, in order to better help doctors assess the risk that a cancer may be hidden in a mammogram,” president and CEO Jeff Wehnes said in prepared remarks.