Data AnalysisVerified
Reviewed and published by trentmaziarz, July 9, 2026. Discovered and drafted by our automated research pipeline.
Hologic offers Quantra breast density assessment software, a machine learning tool that automatically analyzes mammography images and assigns patients to one of four breast density categories, reducing reliance on subjective visual assessment by radiologists. Version 2.2 received FDA 510(k) clearance in November 2017.
Details
Quantra software uses a machine learning algorithm to analyze both 2D and 3D tomosynthesis mammography images for the distribution and texture of breast tissue, then classifies each patient's breast density into one of four categories aligned with American College of Radiology BI-RADS standards. The software runs directly on Hologic's 3Dimensions and Selenia Dimensions mammography system acquisition workstations, eliminating the need for a separate server. Results are displayed at the point of care and can serve as automatic input for downstream breast cancer risk assessment models.
Products affected
Quantra 2.23Dimensions Mammography SystemSelenia Dimensions Mammography SystemCenova Image Analytics Server
Sources & Evidence
Cite this record
Trace Foundation. (2026). Hologic: Hologic offers Quantra breast density assessment software, a machine learning tool that automatically analyzes mammography images and assigns patients to one of four breast density categories, reducing reliance on subjective visual assessment by radiologists. Version 2.2 received FDA 510(k) clearance in November 2017 (data as of 2026-07-09) [Data set record]. AI Trace. https://www.aitrace.org/r/practice/6435eb8a-278c-41d9-b672-2167774b1987. Accessed October 7, 2026.
- Stable link
- https://www.aitrace.org/r/practice/6435eb8a-278c-41d9-b672-2167774b1987
- Data as of
- July 9, 2026
- Last verified
- Not recorded
Other practices by Hologic
ProductivityHologic deployed 3DQuorum Imaging Technology, an AI-powered tool that condenses large 3D mammography image sets into a smaller, more manageable set of 'SmartSlices' to reduce the time radiologists spend reading each exam. The technology received FDA approval in November 2019 and launched commercially in Europe in October 2020.Data AnalysisHologic deployed Genius AI Detection, a deep learning software that analyzes 3D mammography images and flags areas suspicious for breast cancer for radiologist review. The software received FDA clearance in December 2020 and is used with Hologic's 3D Mammography systems.Data AnalysisHologic offers Genius AI Detection PRO, a next-generation breast imaging AI solution that analyzes both current and prior mammogram exams, auto-generates pre-populated exam reports, and provides color-coded case scoring to help radiologists work more efficiently. The product was introduced at RSNA in December 2024 and received a MedTech Breakthrough Award in May 2025.
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