VuCOMP Receives Premarket Approval for CAD Digital Mammography System.

VuCOMP Inc. has received premarket approval from the U.S. Food and Drug Administration (FDA) for its M-Vu CAD Version 3 system for digital mammography. This latest generation of CAD [computer-aided design) technology drives the false positive rate down further than VuCOMP’s M-Vu Version 2. The company has rolled out the new, upgraded system to all M-Vu users at no additional charge.

The M-Vu CAD system uses advanced computer vision algorithms to identify areas of a mammogram that are consistent with breast cancer. M-Vu CAD Version 1 was the first product to meet the FDA-recommended reader study standard for proving the effectiveness of mammography CAD. Version 3 is the second upgrade since Version 1 and debuts only a year after the previous release.

The key advancement of the new M-Vu CAD is its ability to weed out false positive marks, making this latest version of VuCOMP’s CAD system an effective tool for detecting breast cancer, the company claims.

“We are very excited about our new Version 3, as it is capable of 97 percent sensitivity for microcalcifications and 87 percent sensitivity for masses, while maintaining a total false positive rate of only 0.26 marks per image (1.0 false positives per four-view study),” President/CEO Jeff Wehnes said. “We believe that CAD becomes dramatically more valuable to doctors as we drive down the false positive rate while improving sensitivity. We want to provide radiologists with the most powerful and rapidly-advancing CAD technology.”

M-Vu Version 3 is approved for digital mammography systems manufactured by Carestream, Fujifilm, GE, Giotto, Hologic, Konica Minolta, Philips, Planmed, and Siemens.