PLANO, Texas–(BUSINESS WIRE)–VuCOMP, Inc., developer
of computer-aided detection (CAD) systems for automatic analysis of medical
imagery, is pleased to announce 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 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, commented, “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.”
Pisano added, “I look forward to the continued development
of the M-Vu CAD system. I believe that the advances offered by this new
generation of CAD will provide significant clinical value to both the
radiologist and patient alike.”
“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 chief
executive officer, VuCOMP, Inc.
About VuCOMP, Inc.
VuCOMP, Inc. is a private company that designs and develops computer-aided
detection systems (CAD) for automatic analysis of medical imagery. VuCOMP is
dedicated to providing an unprecedented level of detection technology to help
doctors find disease at earlier stages. For more information, please visit www.vucomp.com.