Hologic software nets FDA clearance

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Hologic, a developer and supplier of diagnostics, medical imaging systems and surgical products for the healthcare needs of women, has received FDA clearance for the R2 Quantra volumetric breast density assessment tool.

Quantra is a software application intended for use with Hologic digital mammography systems that provides radiologists with an automated method for assessing breast density, the company said.

The Bedford, Mass.-based Hologic said it creates an internal 3D model of the breast from which it derives estimates of the fibroglandular tissue volume and total breast volume; volumetric breast density is the ratio of these values. Using the Quantra tool to provide numeric values for each breast may aid radiologists in the assessment of breast tissue composition without the subjectivity of human interpretation.