Hologic, Inc.,an innovative medical technology company, has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its Quantra 2.2 Breast Density Assessment Software, which enables clinicians to provide women with consistent breast density assessments during routine breast cancer screenings.
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. Quantra software categorizes breasts into four categories of density, in alignment with the ACR BI-RADS 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.
"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," said Pete Valenti, Hologic's Division President, Breast and Skeletal Health Solutions. "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, Hologic's Genius 3D Mammography exam became the only mammogram approved by the FDA as superior to standard 2D mammography for routine breast cancer screening for women with dense breasts. The updated labeling was based on clinical studies proving that the exam improves invasive breast cancer detection while reducing unnecessary recalls among women of all breast densities. The expanded labeling provides clarity for physicians who previously were unsure how to screen patients with dense breasts.
Quantra software is available for use with Hologic 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. On display at RSNA for the first time, the 3Dimensions system offers a variety of features designed to provide higher quality 3D images for radiologists, enhanced workflow for technologists, and a more comfortable mammography experience, with low-dose options, for patients.
The Genius 3D Mammography exam (also known as the Genius exam) is only available on a Hologic 3D Mammography system. It consists of a 2D and 3D image set, where the 2D image can be either an acquired 2D image or a 2D image generated from the 3D image set. There are more than 4,000 Hologic 3D Mammography systems in use in the US alone, so women have convenient access to the Genius exam.
The Quantra software requires the Hologic Cenova Server and minimal technical specs. Hologic Cenova and Quantra products are only available on Hologic mammography systems.
Hologic, Inc. is an innovative medical technology company primarily focused on improving women's health and well-being through early detection and treatment.