M-Vu is intended 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, according to VuCOMP.

Reader studies performed by lead investigator Dr. Etta Pisano at the University of North Carolina in Chapel Hill indicate that physicians using M-Vu were more effective in reading mammograms, with a significant increase in their ability to discriminate between cancerous and benign tissue, the firm said.

VuCOMP said it is also developing a version of M-Vu that works with full-field digital mammography systems.