Vendors whet radiologists’ appetite for CR mammography

November 27, 2006

Computed radiography arrived at the RSNA meeting Sunday ready for sale into the U.S. market as a mammography application. At the head of the pack was Fujifilm Medical Systems USA, the only vendor with FDA approval to sell CR for mammography. It received the agency green light in July.

Computed radiography arrived at the RSNA meeting Sunday ready for sale into the U.S. market as a mammography application. At the head of the pack was Fujifilm Medical Systems USA, the only vendor with FDA approval to sell CR for mammography. It received the agency green light in July.

The company demonstrated to physicians at its booth how they can operate this modality, showing how single- and multicassette readers function in different clinical environments. The ClearView-CSm multiplate reader can handle up to 20 patients per hour or about the volume of three screening mammography exam rooms. The ClearView-1m is a single-cassette reader.

Other CR vendors elbowed into the limelight the works-in-progress they hope will be competing soon with the Fuji system. Kodak may be closest to market. Several weeks ago, the company filed with the FDA the final module of its premarket approval submission containing clinical data to support the use of its CR mammography product. Modules filed earlier have already been reviewed by the agency, but PMA submissions typically require at least 180 days for review.

Kodak CR products for mammography are already selling outside the U.S. If and when they are approved by the FDA, CR 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 cassettes.

Two other CR vendors, Agfa and Konica Minolta, are waiting for regulators to change the review process. This effort, now under way, could take until next year or longer. The FDA plans to reclassify CR mammography devices from a Class III to the less restrictive Class II. This change would allow a faster, simpler 510(k) evaluation rather than a PMA one. In the meantime, Agfa and Konica are selling mammography-ready CR systems outside the U.S.

At the RSNA meeting, Agfa demonstrated its high-throughput CR 85-X and single-plate CR 35-X in configurations compatible with mammography. Each was displayed as a work-in-progress. The CR 85-X is currently on the U.S. market but only for general radiography. The CR 35-X has not yet been released in any form. Both readers can be made mammography-ready with a simple software upgrade.

Konica displayed its Regius Express CR for mammography as a product pending FDA review, eschewing the otherwise typical work-in-progress moniker borne by most devices awaiting the go-to-market seal of U.S. regulators. The Regius Express reader, currently sold in the U.S. as a general-purpose product, will require very little to upgrade for mammography, specifically software to upgrade the workstation to include 43.75-micron capability for mammography and a quality assurance program.