VuCOMP has received premarket approval (PMA) from the FDA for its M-Vu computer-aided detection (CAD) version 3 system for digital mammography. The new version lowers the false positive rate of its predecessor and comes just a year after the company released version 2.
The M-Vu CAD system uses computer algorithms to identify regions of a mammogram that might indicate breast cancer. The system was the first to meet the FDA’s recommended reader study standard for proving the effectiveness of mammography CAD. The company has provided the upgrades at no additional charge to its customers.
“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),” said Jeff Wehnes, president and CEO of VuCOMP. “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. For more information, visit VuCOMP.
