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.
That means clinics that host a variety of systems from a variety of vendors can rely on a single CAD solution, VuCOMP noted.
The system is also the only FDA-approved mammography CAD to have met the FDA’s requirements that the system demonstrate, through comprehensive reader studies, that radiologists are more effective in detecting breast cancer when using CAD, according to a press release.
The Version 2 M-Vu also aims to cut back on noise and false-positives in analyzing mammogram images.
"We are seeing far fewer marks with VuCOMP’s CAD than with our current CAD system, and the marks make more sense to me," Boston Breast Diagnostic Center medical director Dr. Elsie Levin said in prepared remarks. "When there are many marks across 4 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."
VuCOMP in January won FDA premarket approval for the original system.
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