EU approves Scanis mammography system

Software designed to automatically locate and highlight subtle abnormalities is part of a computer-aided mammography system that recently gained European marketing approval.

The Mammex TR is a computer-aided diagnosis system intended to help radiologists improve their accuracy in evaluating mammograms. The Foster City, CA, company did much of the early development and testing of the technology with the University of California, San Francisco, and Stanford University.

According to Scanis, proprietary rule-based algorithms and filters identify and classify small and obscure features of diagnostic interest. In other words, the software is designed to find subtle abnormalities the radiologist may have missed. It works by digitizing film mammograms and displaying them on a monitor so the radiologist can compare them to the original.

Now that the Mammex TR has obtained the CE Mark under the European Union's Medical Device Directive, Scanis will be starting the FDA premarket approval process in the next few months, according to company spokesperson Bob Chapman. A Canadian application is expected to be approved shortly, he said.

"We have a close relationship with the University of Southern California, which is developing a protocol," Chapman said. "and we will be working with several more institutions."