VuCOMP receives PMA for M-Vu CAD system

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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.

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