Compelo Medical Devices - Latest industry news and analysis is using cookies

We use them to give you the best experience. If you continue using our website, we'll assume that you are happy to receive all cookies on this website.

ContinueLearn More

VuCOMP M-Vu system gets FDA PMA

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.