Technology | Breast Density | November 28, 2017

Hologic Receives FDA 510(k) Clearance of Quantra 2.2 Breast Density Assessment Software

Software provides patient-specific breast density according to BI-RADS 5th Edition categories

Hologic Receives FDA 510(k) Clearance of Quantra 2.2 Breast Density Assessment Software

November 28, 2017 — 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 enables clinicians to provide women with consistent breast density assessments during routine breast cancer screenings.

Quantra 2.2 is one of several products that will be available for demonstration in Hologic's booth at the 103rd Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA), Nov. 26-Dec. 1 in Chicago.

Through a proprietary algorithm powered by machine learning, Quantra software analyzes mammography images for distribution and texture of breast tissue, delivering clinicians patient-specific breast density assessment. The software categorizes breasts into four categories of density, in alignment with the ACR BI-RADS (Breast Imaging-Reporting and Data System) Atlas 5th Edition.

Nearly half of women between the ages of 40 and 74 have dense breasts, which can make it difficult to detect breast cancer during annual screenings and lead to 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. Breast density is only identifiable on a mammogram or other screening modality, and has historically been determined by the radiologist who reads the image. With Quantra software, clinicians can feel confident they are providing their patients with an unbiased breast density assessment that removes the potential for visual subjectivity.

Quantra software is available for use with Hologic 3-D Mammography systems, including the new 3Dimensions mammography system, with the Intelligent 2-D imaging technology (which is still pending FDA approval). On display at RSNA for the first time, the 3Dimensions system offers a variety of features designed to provide higher quality 3-D images for radiologists, enhanced workflow for technologists, and a more comfortable mammography experience, with low-dose options, for patients.

In addition to the 3Dimensions system, RSNA attendees can experience Hologic's comprehensive portfolio of breast and skeletal health products designed to deliver improved patient satisfaction, better clinician workflow and facility cost savings. They can also visit Hologic's "New Product Theater," where representatives from the company's screening, interventional and skeletal teams will present every hour during exhibition times. Presentations will feature new products including the 3Dimensions system, Brevera breast biopsy system with CorLumina imaging technology, and Fluoroscan InSight FD Mini C-Arm extremities imaging system, all of which will be showcased on the exhibit floor.

Throughout the show, Hologic will host a number of interactive workshops and educational symposia, two of which will address the impact that breast tomosynthesis and breast density assessment software can have on clinicians and women with dense breasts. Additional workshops will focus on topics including contrast-enhanced 2-D mammography, advancements in 3-D Mammography, and 3-D image-guided biopsy solutions.

For more information: www.hologic.com

 

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