美国食品和药物管理局（FDA）已经通过了VuCOMP的M-Vu计算机辅助检测（CAD）系统的上市前批准（PMA）

MDBR Staff Writer Published 19 October 2012

The US Food and Drug Administration (FDA) has cleared VuCOMP's premarket approval (PMA) application for new version of M-Vu computer-aided detection (CAD) system.

The new CAD system, M-Vu version 2, is designed for use in digital mammography to find breast cancer earlier.

Boston Breast Diagnostic Center medical director Elsie Levin said the center is seeing far fewer marks with VuCOMP's CAD than with current CAD system.

"When there are many marks across four images, as with some other CAD systems, your mind automatically tends to dismiss them," Levin added.

"Obviously, we do look at each mark, but it can be frustrating because there are just so many that don't show any suspicious signs.

"With VuCOMP's CAD, because we're seeing far fewer marks, I have more confidence that these are significant findings."

VuCOMP president and CEO Jeff Wehnes said the company's goal in mammography CAD is to continue to make dramatic reductions in false positive rates, while at the same time increase detection sensitivity to even higher levels.

"Our R&D team is dedicated to ongoing development of enhanced performance CAD solutions for radiologists worldwide, and we intend to deliver significant upgrades on a regular basis," Wehnes added.

The company said M-Vu CAD is now approved for digital mammography systems manufactured by Carestream, Fuji, GE, Giotto, Hologic, Konica Minolta, Philips, Planmed, and Siemens.