VuCOMP Gets FDA Approval for Mammo CAD System

February 6, 2012

Computer-aided detection system developer VuCOMP Inc. has received FDA premarket approval for its film mammography CAD software.

Computer-aided detection system developer VuCOMP Inc. has received FDA premarket approval for its film mammography CAD software. This is the first new mammography CAD system approved by the FDA since 2007, the company said.

M-Vu is indicated for use in screening mammography to identify areas consistent with breast cancer for radiologist review after completing an initial read, according to the company.

In a reader study at the University of North Carolina at Chapel Hill, physicians using the M-Vu CAD system were more effective at reading mammograms and demonstrated a significant increase in the ability to discriminate between cancer and noncancer, according to VuCOMP.

The company will be providing a digital version of the system in the “near future,” VuCOMP president and CEO Jeff Wehnes said in a statement.