Statlife has received U.S. FDA 510(k) clearance for DenSeeMammo, a software solution for breast density category assessment. DenSeeMammo provides a standardized and automatic breast density evaluation that mimics radiologists’ visual assessment according to the Breast Imaging Reporting and Data System (BIRADS) 5th Edition guidelines.
DenSeeMammo estimates BIRADS breast density value by analyzing digitally processed 2D mammograms using a fully automated comparison procedure. What’s more, the images from the mammography equipment are compared to a database of images that were previously quoted by a consensus of Mammography Quality Standards Act radiologists specialized in breast imaging.
Stephane Ragusa, CEO of Statlife, spoke out about the technology, saying: “DenSeeMammo provides a breast density assessment in agreement with a radiologist’s visual assessment but in a very reproducible way. When DenSeeMammo is combined with our other software tool, MammoRisk, for breast cancer risk assessment, it provides a breast density category assessment, a risk evaluation, and a patient report with a personalized screening program.”
Finally, DenSeeMammo is compatible with images obtained from GE Senographe Essentials systems.
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