Technology | April 24, 2015

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

News | RSNA

July 23, 2024 — Professional registration is open for RSNA 2024, the world’s largest radiology forum. This year’s theme ...

Time July 23, 2024
News | Flat Panel Displays

July 17, 2024 — LG Electronics (LG) is accelerating its B2B medical device business, expanding its lineup of diagnostic ...

Time July 17, 2024
Feature | Imaging Technology News - ITN

Be sure to check out the latest digital edition of Imaging Technology News (ITN), featuring the Mobile C-arm Systems ...

Time July 11, 2024
Feature | Radiology Business

The ITN team wishes you a safe and happy 4th of July!

Time July 04, 2024
News | Breast Imaging

July 2, 2024 — Delphinus Medical Technologies, a pioneering medical imaging company that developed the SoftVue Breast ...

Time July 02, 2024
News | Artificial Intelligence

June 27, 2024 — Clarius Mobile Health, which provides high-definition handheld ultrasound systems, has obtained U.S ...

Time June 27, 2024
News | Breast Imaging

June 20, 2024 — The technologically advanced VELA Mammography Chair, offered by Enable Me, a VELA Medical company ...

Time June 20, 2024
News | Breast Imaging

June 18, 2024 — Delphinus Medical Technologies, a pioneering medical imaging company that developed the SoftVue Breast ...

Time June 18, 2024
News | Digital Radiography (DR)

June 12, 2024 — Carestream launched its Image Suite MR 10 Software to help deliver a boost to productivity and ...

Time June 12, 2024
News | Breast Imaging

June 7, 2024 — Scholars and studies funded by Susan G. Komen(R), the world’s leading breast cancer organization ...

Time June 07, 2024
Subscribe Now