Technology | April 24, 2015

VuComp Files PMA for Computer-Aided Detection for Digital Breast Tomosynthesis

Submission includes clinical validation and internal software testing for CAD plus digital radiography versus DR alone

VuComp, M-Vu CAD, digital breast tomosynthesis, DBT

April 24, 2015 — VuComp Inc. announced that it has submitted to the U.S. Food and Drug Administration (FDA) its premarket approval application (PMA) for computer-aided detection (CAD) for digital breast tomosynthesis (DBT).

The CAD system is designed to use VuComp proprietary computer vision algorithms (M-Vu Algorithm Engine) to identify areas of mammograms consistent with breast cancer.

The submission includes both clinical validation and internal software testing that compares CAD performance of DBT and digital radiography (DR) images to DR images alone.  

Use of CAD with breast tomosynthesis is expected to re-ignite CAD for the mammography market. Installations of tomosynthesis systems are expected to increase four-fold in the United States by 2016. With tomosynthesis adoption continuing to grow, demand for a tool to help the radiologist assess the vast amount of data is expected. Tomosynthesis provides 50 to 100 times as much data as 2-D mammography studies.

Debra Somers Copit, M.D., FACR, director, breast imaging, Einstein Healthcare Network and associate professor of radiology, Jefferson Medical College commented, “DBT clearly decreases the recall rates for screening mammography and increases invasive cancer detection. Yet, there is a critical role for CAD not only for the radiologist new to tomosynthesis, but also those who have had more experience, given the vastly increased amount of information presented to the reader.”

VuComp anticipates the launch of their CAD for tomosynthesis solution no later than the fourth quarter of 2015.

VuCOMP’s M-Vu CAD system meets the FDA standard that recommends comprehensive reader studies to prove the effectiveness of CAD systems.

For more information:

Related Content

Novel Technique May Significantly Reduce Breast Biopsies
News | Breast Biopsy Systems | January 17, 2019
A novel technique that uses mammography to determine the biological tissue composition of a tumor could help reduce...
Digital Mammography Increases Breast Cancer Detection
News | Mammography | January 16, 2019
The shift from film to digital mammography increased the detection of breast cancer by 14 percent overall in the United...
Artificial Intelligence Used in Clinical Practice to Measure Breast Density
News | Artificial Intelligence | January 15, 2019
An artificial intelligence (AI) algorithm measures breast density at the level of an experienced mammographer,...
Sponsored Content | Videos | Breast Imaging | January 11, 2019
Supplemental screening with ABUS helps personalize breast care for women with dense breasts and offers advanced...
Electronic Brachytherapy Effective in Long-Term Study of 1,000 Early-Stage Breast Cancers
News | Brachytherapy Systems, Women's Healthcare | January 07, 2019
Breast cancer recurrence rates of patients treated with intraoperative radiation therapy (IORT) using the Xoft Axxent...
Breast Cancer Patients Have Less Heart Damage With Heart Drug and Trastuzumab
News | Cardio-oncology | January 03, 2019
Breast cancer patients who take a heart drug at the same time as trastuzumab have less heart damage, according to a...
Opto-Acoustic Imaging Helps Differentiate Breast Cancer Molecular Subtypes
News | Ultrasound Women's Health | December 20, 2018
Seno Medical Instruments Inc. (Seno Medical) reported results of a study demonstrating that morphologic and functional...
Densitas Enters Platform Partnership With Blackford
News | Breast Density | December 19, 2018
Breast imaging analytics company Densitas Inc. announced the signing of a new Alliance Partner Agreement with Blackford...
Axillary Radiotherapy and Lymph Node Surgery Yield Comparable Outcomes for Breast Cancer
News | Radiation Therapy | December 18, 2018
Early-stage breast cancer patients with cancer detected in a sentinel lymph node biopsy had comparable 10-year...
Videos | Artificial Intelligence | December 13, 2018
ITN Editor Dave Fornell and ITN Contributing Editor Greg Freiherr share their insights on the vendors showing...