Breast cancer: VuCOMP wins expanded PMA for digital mammogram analysis
VuCOMP lands FDA approval for its 2nd-generation M-Vu computer-aided detection system for automatic analysis of digital mammography images.
Medical imaging analysis devices maker VuCOMP touted FDA premarket approval for its new M-Vu system for helping radiologists detect breast cancer earlier.
The Version 2 M-Vu system's new indication allows the company to market its devices as an computer-aided detection adjunct to digital mammography.
The next-generation system is approved to work with twice as many vendors as any other mammography CAD product, including those by Philips (NYSE:PHG), Siemens (NYSE:SI), Hologic (NSDQ:HOLX) and others, according to a press release.