Technology | February 06, 2012

VuCOMP Receives FDA Approval for Mammography Computer-Aided Detection System


February 6, 2012 — A developer of computer-aided detection (CAD) systems for automatic analysis of medical imagery, VuCOMP, Inc. announced premarket approval (PMA) of M-Vu, a cutting-edge CAD system for film mammography. M-Vu is indicated for use in screening mammography to identify areas consistent with breast cancer for radiologist review after completing an initial read. This is the first new mammography CAD system approved by the U.S. Food and Drug Administration (FDA) since 2007. 

A reader study performed at the University of North Carolina at Chapel Hill proved that physicians were more effective at reading mammograms when using the M-Vu CAD system. Etta Pisano, M.D., primary investigator for the study, said, “Physicians using M-Vu demonstrated a significant increase in their ability to discriminate between cancer and non-cancer. This is an exciting advancement for mammography CAD.” 

“We are very pleased with the approval of M-Vu for film-screen mammography and are excited to turn our focus toward providing a digital version in the near future,” said Jeff Wehnes, president and CEO, VuCOMP, Inc.

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