FDA Approves First-of-Its-Kind Breast Density Category Assessment Software
Boston, MA (PRWEB) December 13, 2016
Statlife is proud to announce FDA 510(k) clearance of 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 BIRAD 5th Edition guidelines. The images from the mammography equipment are compared to a database of images that were previously quoted by a consensus of MQSA radiologists specialized in breast imaging.
According to Stephane Ragusa, CEO of Statlife, “DenSeeMammo provides a breast density assessment in agreement with a radiologist’s visual assessment but in a very reproducible way. Only the breast density visually assessed by radiologists is recommended by the BIRAD Atlas V and is clinically significant considering the masking effect and the correlation with breast cancer risk. 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. To date, we are the only company on the market able to offer our customers an end-to-end software solution that complies with US breast density law requirements.”
- DenSeeMammo is a unique and innovative medical device as it produces an automatic assessment of breast density simulating visual evaluation but in a reproducible way.
- DenSeeMammo is a software application intended for use with digital mammography systems. DenSeeMammo estimates BIRADs breast density value by analyzing digitally processed 2D mammograms using a fully automated comparison procedure.
- DenSeeMammo provides a BIRADs breast density 5th Edition category to aid radiologists in the assessment of breast density.
- DenSeeMammo produces adjunctive information. It is not an interpretive or diagnostic aid when the final assessment of breast density category is made by an MQSA qualified interpreting physician.
- DenSeeMammo is compatible with images obtained from GE Senographe Essentials systems.
Founded in 2004 and headquartered in Paris, France, with a US location in Boston, MA, Statlife specializes in statistics and data mining applied to 4P medicine: predictive, preventive, personalized, and participative. Its first major product is Mammorisk, an innovative software that can be used to estimate the risk of developing breast cancer, using five simple criteria. It is intended for radiologists, gynecologists, and general practitioners.
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