VuCOMP Inc. said Thursday it received Food and Drug Administration approval for version two of its M-Vu digital mammography computed-assisted detection system.
The Plano, Texas-based company said that the M-Vu is the only FDA-approved mammo CAD product to meet stricter new FDA guidelines. These call for "comprehensive reader studies proving that radiologists are more effective when they use CAD," according to the company.
The FDA released its guidance documents on CAD over the summer.
The product works with devices from Carestream, Fuji, GE, Giotto, Hologic, Konica Minolta, Philips, Planmed and Siemens, the company said.
VuCOMP received FDA approval for the film mammo version of the software at the beginning of the year.
