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VuCOMP's Gains Wider FDA OK for Breast Cancer Detection Device


10/18/2012 9:57:57 AM

PLANO, Texas--(BUSINESS WIRE)--VuCOMP, Inc. announced today that it has received FDA premarket approval (PMA) for Version 2 of its M-Vu CAD system for digital mammography. M-Vu CAD is designed to provide an unprecedented level of performance to help radiologists find breast cancer earlier. FDA guidelines now recommend 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 is now 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.

FDA guidelines now recommend 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 is now 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.

“We are seeing far fewer marks with VuCOMP’s CAD than with our current CAD system, and the marks make more sense to me,” stated Elsie Levin, M.D., Medical Director of Boston Breast Diagnostic Center. Dr. Levin went on to say, “When there are many marks across four images, as with some other CAD systems, your mind automatically tends to dismiss them. Obviously, we do look at each mark, but it can be frustrating because there are just so many that don’t show any suspicious signs. With VuCOMP’s CAD, because we’re seeing far fewer marks, I have more confidence that these are significant findings. This allows me to spend my time more efficiently.”

Jeff Wehnes, President and CEO of VuCOMP added, “We are pleased that this study has validated our new version of M-Vu CAD designed for digital mammography. Our goal in mammography CAD is to continue to make dramatic reductions in false positive rates, while at the same time increasing detection sensitivity to even higher levels. Our R&D team is dedicated to ongoing development of enhanced performance CAD solutions for radiologists worldwide, and we intend to deliver significant upgrades on a regular basis.”

About VuCOMP, Inc.

VuCOMP, Inc. is a private company that designs, develops, and markets computer-aided detection systems (CAD) for automatic analysis of medical images. The employees of VuCOMP are dedicated to providing an unprecedented level of detection technology to help radiologists find disease at earlier stages and save lives. For more information, please visit www.vucomp.com.

Contacts

VuCOMP, Inc.
Richard Tabbutt, 888-266-7462 x434
richard.tabbutt@vucomp.com
or
Beacon Communications
Dan Conley, 312-593-8461
dconley@beaconpr.com


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