VuCOMP Third-Generation M-Vu® Computer-Aided Detection (CAD) System Receives FDA Approval

VuCOMP has announced FDA premarket approval (PMA) of the M-Vu CAD Version 3 system for digital mammography.

This latest generation of CAD technology drives the false positive rate down even further than VuCOMP’s proven M-Vu Version 2. 

The key advancement of the new M-Vu CAD is its substantial reduction of false positive marks, making this latest version of VuCOMP’s CAD system an even more effective tool for radiologists searching for breast cancer.

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 significant upgrade since Version 1 and comes to the market only a year after the previous release, fulfilling the company’s commitment to ongoing enhancements for its customers at no additional cost. The Company has just completed rolling out the new, upgraded system to all M-Vu users at no additional charge.

Jeff Wehnes, President and CEO of VuCOMP, said “We are very excited about our new Version 3, as it is capable of 97% sensitivity for microcalcifications and 87% 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). 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 in the world.”

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

Source: VuCOMP