PLANO, Texas--(BUSINESS WIRE)--VuCOMP, Inc., leading developer of advanced computer vision systems for the detection of breast cancer, announced today 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.
"This important PMA submission demonstrates our continued focus on developing the most advanced technologies for the early detection of breast cancer, as well as providing radiologists with tools that will impact their diagnostic confidence," said Jim Pike, Chief Technology Officer, VuCOMP. “By being the first company to submit a PMA for CAD for breast tomosynthesis, VuCOMP once again stakes its claim as the market leader.”
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 U.S. 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 2D mammography studies.
Debra Somers Copit, MD, 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 was the first mammography CAD product to meet the rigorous FDA standard that recommends comprehensive reader studies to prove the effectiveness of CAD systems.
About VuCOMP, Inc.
VuCOMP, Inc. leads the way in setting a new standard for computer-aided detection. The company is dedicated exclusively to developing advanced cancer detecting technologies. VuCOMP’s engineering team has worked together since 1986, pioneering some of the world’s most advanced computer vision systems. For more information, please visit www.vucomp.com.
