FDA gives green light for VuCOMP's M-Vu CAD system

VuCOMP has received the FDA's PMA for version two of its M-Vu Computer-Aided Detection (CAD) system for digital mammography. M-Vu CAD is designed to help radiologists find breast cancer earlier. FDA guidelines have recommended comprehensive reader studies proving that radiologists are more effective when they use CAD. The M-Vu system is the only FDA-approved mammography CAD product that meets these recommendations.

M-Vu CAD has been approved for digital mammography systems manufactured by Carestream, Fuji, GE, Giotto, Hologic, Konica Minolta, Philips, Planmed and Siemens. Consequently, the M-Vu system is approved for more than twice as many vendors as any other mammography CAD product. For clinics using a variety of digital mammography systems, M-Vu CAD can now provide a unified CAD solution.

VuCOMP's CAD eliminates any extra marks that are observed with current CAD systems, allowing oncologists to see far fewer marks, enabling greater confidence and allowing oncologists to view these marks as significant findings.

This article is tagged to:
Sector: Medical Devices
Geography: United States

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