Technology | February 06, 2014
FDA Clears VuComp’s Third-Generation Computer-Aided Detection System
System Advances Performance in Mammography CAD
February 6, 2014 — VuComp received U.S. Food and Drug Administration (FDA) premarket approval (PMA) of the M-Vu CAD Version 3 system for digital mammography. This generation of CAD technology intends to lower false positive rates. The company upgraded all M-Vu users’ systems with M-Vu CAD Version 3 at no 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 met the FDA-recommended reader study standard for proving the effectiveness of mammography CAD.
The key advancement of the new M-Vu CAD is its reduction of false positive marks for breast cancer.
Version 3 is capable of 97 percent sensitivity for microcalcifications and 87 percent sensitivity for masses. Total false positive rates measure at 0.26 marks per image (1 false positives per four-view study).
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: www.vucomp.com