Companies add digital features to full-field scanners

Mammography CAD leads the way

By Steve Wagner

As applications for full-field digital imaging expand, the relationships developing among manufacturers are becoming increasingly important. That was underscored during the RSNA meeting in November.

During the meeting, several high-profile companies with pending or FDA-cleared digital mammography systems highlighted their key imaging partners. One was Fischer Imaging, which predicts its SenoScan digital mammography system will receive FDA clearance before year's end.

Fischer and CADx Medical Systems will be integrating CADx's Second Look computer-aided detection (CAD) technology into SenoScan. The two will collaborate on product integration as well as acquisition of the regulatory clearances needed to market the technology in the U.S.

"This relationship will positively impact the review process for breast cancer screening," said Jim Corbett, vice president of commercial operations for CADx Medical Systems. "It will allow us to do digital mammography and CAD for the next generation."

Like Fischer, CADx is awaiting word from the FDA for Second Look. It, too, anticipates approval by year-end, which would make it the second company to receive approval for its CAD technology. The other is R2 Technology of Los Altos, CA.

To expedite things, CADx has submitted its FDA application in phases, a strategy that seems to be working.

"We took a modular approach to approval so the FDA could begin working on the areas we had completed," said Corbett. "We felt that would move the process along faster."

Second Look is designed to identify potentially suspicious lesions on mammograms, theoretically enabling radiologists to detect cancer more easily and thus make earlier diagnoses.

"CAD is going to be one of the very significant opportunities with digital mammography," said Morgan W. Nields, chairman and president of Fischer. "With CAD and telemammography coming along, this technology will add considerable productivity to radiology (in reading mammograms)."

CADx also announced it has signed a letter of intent with Lorad to market Second Look as a component of Lorad's full-field digital mammography system. Lorad is now a division of Hologic.

Meanwhile, Fuji and Siemens announced a long-term supply agreement that allows Siemens to offer its customers Fuji's computed radiography technology as part of its own full-field digital mammography system worldwide, and in the U.S. when the technology clears the FDA.

No system currently on the market offers CR technology for mammography, Siemens representatives said.

Fuji's technology is already being used in more than 12,000 installations worldwide. Dual-side reading and 50-µm reading technology were instrumental in enabling its use in mammography applications, the company said.