Kodak readies CR mammography WIP

Kodak will showcase its computed radiography platform for mammography at the RSNA meeting, but it will have to do so as a work-in-progress, at least for customers in the U.S.

The company last week filed the final module of its premarket approval submission to the FDA (DI SCAN, 11/10/06, Kodak submits CR mammography data to FDA). Modules filed earlier have already been reviewed by the agency, but this one, which contains clinical data from trials done at sites in the U.S. and Canada, could take awhile. PMA submissions typically require at least 180 days for review.

"Clearly, we would like to hope it would go faster, because they have closed two modules already, but that is out of our control," said Stephen Archer, director of worldwide marketing for mammography solutions in the Kodak Health Group. "I'll be diplomatic and say I would like to hope it wouldn't take any longer."

Kodak's submission, now in review at the FDA, will not be affected by the agency's effort to reclassify CR mammography devices from a class three to the less restrictive class two. This reclassification would allow a faster and simpler 510(k) evaluation. Meanwhile, the company has chosen to go forward with the PMA process, Archer said.

Kodak has been selling CR mammography outside the U.S. for more than a year and has "many hundreds" of such installations, most of them in Europe, he said. This has provided the company with a base of testimonials for prospective U.S. customers to peruse on the Internet.

"It's also given us the background, knowledge, and experience that come with successful installations and happy customers around the world," Archer said. "This is all transferable to the U.S., so we won't be starting from zero."

If and when approved, the mammography capability will appear as an option on the company's DirectView CR 850, 950, and 975 systems and as a retrofit to previously installed systems in these series. Products equipped for mammography will differ from those intended for general radiography in the software and the cassettes. Mammography plates will have pink labeling.

Kodak will feature CAD software developed for its CR-based system at its RSNA booth. This platform will also be groomed to be used with data obtained using full-field digital mammography systems, including ones built by GE and Siemens. The software, like the CR-based mammography feature, will be a work-in-progress.

The company will display its Carestream PACS for mammography system, featuring FDA-cleared versions of software designed for interpreting breast images from other modalities, namely Cedara's B-CAD for ultrasound and Confirma's CADstream for MR.

A mammography module for Kodak's Carestream RIS will debut as a work-in-progress. It will include tools that help automate patient communication and simplify the preparation of reports required by the Mammography Quality Standards Act.

Other companies planning to show CR mammography products at the RSNA meeting include Agfa, which will demonstrate the high-throughput CR 85-X and single-plate CR 35-X in configurations compatible with mammography, each a work-in-progress.

The CR 85-X is currently on the U.S. market but only for general radiography. A mammography version has been selling outside the U.S. since 2003. CR 35-X has not yet been released in any form. Both units can be made mammography-ready with a simple software upgrade.

Fuji is the only vendor with FDA approval to sell CR for mammography, having received the agency's green light to do so in July. The company will demonstrate to physicians at its booth how they can operate this modality, showing how single- and multicassette readers function in different circumstances. The ClearView-CSm multiplate reader, which can handle up to 20 patients per hour or about the volume of three screening mammography exam rooms, and the ClearView-1m, which is a single-cassette reader, will be featured.