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 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: www.vucomp.com