statlife, mammorisk, DenSeeMammo

December 20, 2016 — The U.S. Food and Drug Administration (FDA) has granted  510(k) clearance to Statlife’s DenSeeMammo, a software solution for breast density category assessment. DenSeeMammo provides a standardized and automatic breast density evaluation that mimics radiologists' visual assessment according to the BIRAD 5th Edition guidelines. The images from the mammography equipment are compared to a database of images that were previously quoted by a consensus of Mammography Quality Standards Act (MQSA) radiologists specialized in breast imaging.

 The company said the software provides a breast density assessment in agreement with a radiologist's visual assessment, but in a very reproducible way. Only the breast density visually assessed by radiologists is recommended by the BIRAD Atlas V and is clinically significant considering the masking effect and the correlation with breast cancer risk. 

The DenSeeMammo software can be combined with Statlife’s MammoRisk software for breast cancer risk assessment, it provides a breast density category assessment, a risk evaluation, and a patient report with a personalized screening program. 
 
DenSeeMammo is a software application intended for use with digital mammography systems. DenSeeMammo estimates BIRADs breast density value by analyzing digitally processed 2-D mammograms using a fully automated comparison procedure. It provides a BIRADs breast density 5th Edition category to aid radiologists in the assessment of breast density.

The software produces adjunctive information. It is not an interpretive or diagnostic aid when the final assessment of breast density category is made by an MQSA qualified interpreting physician.

DenSeeMammo is compatible with images obtained from GE Senographe Essentials systems.

For more information: www.mammorisk.com/us


Related Content

News | PET Imaging

May 30, 2025 — GE HealthCare recently announced that the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) ...

Time May 30, 2025
arrow
News | Imaging Software Development

May 27, 2025 — DeepLook Medical, a company advancing medical imaging through visual enhancement technology, recently ...

Time May 28, 2025
arrow
News | Breast Imaging

May 13, 2025 — In one of the larger studies of its kind, researchers have identified six breast texture patterns that ...

Time May 16, 2025
arrow
News | Mammography

April 29, 2025 — iCAD, a global provider of clinically proven AI-powered cancer detection solutions, has announced a ...

Time April 29, 2025
arrow
News | Mammography

April 24, 2025 — GE HealthCare will feature its latest advancements in diagnostic accuracy and patient-centered breast ...

Time April 24, 2025
arrow
News | Breast Imaging

March 20, 2025 — GE HealthCare has launched Invenia Automated Breast Ultrasound (ABUS) Premium, the latest 3D ultrasound ...

Time March 21, 2025
arrow
News | Artificial Intelligence

March 10, 2025 — Lunit, a provider of AI-powered solutions for cancer diagnostics and therapeutics, has published a ...

Time March 10, 2025
arrow
News | Breast Imaging

March 04, 2025 — Optellum has entered a strategic agreement with Volpara Health, a Lunit company and a provider of ...

Time March 04, 2025
arrow
News | Artificial Intelligence

Feb. 19, 2025 — SimonMed Imaging and HeartLung Technologies have signed a strategic partnership to offer HeartLung's AI ...

Time March 04, 2025
arrow
News | Ultrasound Imaging

Jan. 28, 2025 — GE HealthCare recently announced it has received 510(k) clearance from the United States Food and Drug ...

Time January 29, 2025
arrow
Subscribe Now