Computer-aided detection (CAD) developer VuCOMP has submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its CAD software for digital breast tomosynthesis.
The software is designed to use VuCOMP's proprietary computer vision algorithms (M-Vu algorithm engine) to identify areas of mammograms consistent with breast cancer, according to the company.
The submission includes both clinical validation and internal software testing that compares CAD performance for digital breast tomosynthesis and digital radiography (DR) images to DR images alone.
VuCOMP anticipates the launch of its CAD for tomosynthesis software no later than the fourth quarter of 2015.
