VuCOMP has received the premarket approval (PMA) for its M-Vu, a computer-aided detection (CAD) system for film mammography from the US Food and Drug Administartion (FDA).
M-Vu is used in screening mammography to identify areas consistent with breast cancer for radiologist review after completing an initial read.
Study primary investigator Etta Pisano said physicians using M-Vu showed a significant increase in their ability to discriminate between cancer and non-cancer.
"We believe that the advances provided by this new generation of CAD will provide significant clinical value to both the radiologist and patient alike," Pisano said.
VuCOMP president and CEO Jeff Wehnes said they are very pleased with the approval of M-Vu for film-screen mammography and are excited to turn their focus toward providing a digital version in the near future.