FDA clears Hologic’s Quantra 2.2 Breast Density Assessment Software during routine screening mammography

Hologic Inc. announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Quantra 2.2 Breast Density Assessment Software. The software helps radiologists and clinicians to provide information about breast density to women during routine breast cancer screenings.

Quantra standardizes breast density reporting and helps eliminates the visual subjectivity by radiologists, through a proprietary algorithm powered by machine learning. The software classifies the breast tissue into four density categories based on  ACR Breast Imaging Reporting and Data System( ACRBI-RADS®) Atlas 5^th Edition, based on the distribution of fibroglandular tissue  and texture of breast tissue.

The BI-RADS® Atlas provides standardized breast imaging findings terminology, report organization, assessment structure and a classification system for mammography, ultrasound and MRI of the breast.

The Quantra software is compatible with Hologic's 3D Mammography systems, including the new 3Dimensions mammography system, which is designed to be the fastest, highest resolution breast tomosynthesis system ever, with the 'Intelligent 2D imaging technology'.

Nearly 40% of women between the age of 40 and 74 have dense breasts, which can make it difficult to detect breast cancer during annual screenings and necessitates additional imaging, resulting in increased patient anxiety and unnecessary facility costs. Perhaps most importantly, women with very dense breasts are four to five times more likely to develop breast cancer than women with less dense breasts.

The software is one of several groundbreaking products that is available for demonstration in Hologic's booth (#4705) at the ongoing 103rd ScientificAssembly and Annual Meeting of the Radiological Society of North America (RSNA) at McCormick Place in Chicago from Nov. 26 to 30.

Pete Valenti, Hologic's Division President, Breast and Skeletal Health Solutions said, "As the global leader in breast cancer screening technology, we relentlessly pursue the development of clinically superior products that address the unmet and changing needs of our customers and their patients, especially when it comes to breast density. Quantra software is yet another example of our dedication and we are proud to feature it – along with a number of other new, breakthrough products – for the world's leading radiologists at RSNA this week."

Earlier this year, FDA approved its Genius 3D Tomosynthesis Mammography as the only test superior to 2D mammography for routine breast cancer screening for women with dense breasts. 

Hologic also commercially launched its SmartcCurve breast stabilization system at the same time, that makes mammography experience less painful for women without compromising on image quality and diagnostic accuracy.

Hologic Worldwide Quantra Volumetric Breast Density Assessment