Fujifilm prepares clinical data on CR mammography for FDA

Modular approach spreads out submissions

Computed radiography for mammography could be commercially available in the U.S. as early as spring 2004, according to Fujifilm Medical Systems USA.

The company has gathered all the necessary clinical data, according to John Strauss, director of marketing for Fuji imaging systems, including a one-year follow-up on patients diagnosed as normal during the clinical trials. These data could be submitted as early as next month.

Other data have either been submitted or are awaiting collection by FDA reviewers as part of the company's modular approach to winning a premarket approval (PMA) for the device. Nonclinical data about the capabilities and features of the CR mammography device are currently being submitted to the FDA. Data about the manufacturing of the device still need to be examined by the agency.

The focal point of these efforts is Fuji's latest CR system, ClearView-CS, which is scheduled for commercial launch in October for nonmammographic applications (SCAN 6/25/03). (The SCAN article incorrectly stated that clinical data supporting mammographic applications would be submitted in April 2004. As noted above, these data are expected to be in reviewers' hands some eight months earlier.) A field upgrade to the ClearView-CS will be made available to installed sites, and factory units will be reconfigured for digital mammography, if and when the FDA approves the marketing of the system for this purpose, Strauss said.

As with any PMA, the clinical data are the key to the device's ultimate approval for marketing in the U.S., and Fuji executives are confident that the information collected during trials will stand up to scrutiny. Fuji sought and incorporated feedback from the regulatory agency into the design of these studies to help ensure that the review would go smoothly.

The company's analysis of the data is now complete and the final touches are being put on the clinical module, according to Strauss. As with other digital full-field mammography devices, Fuji must satisfy a null hypothesis, that its CR device is equivalent to-neither better nor worse than-existing film-based mammography systems. The greatest challenge has been getting the right classification of patients enrolled to accomplish this goal.

"We provide the FDA with a higher percentage of cancers than is commonly found in the general population to emulate a larger patient study," Strauss said. "This is necessary to demonstrate that we are detecting only cancers as seen on film without generating false-positive results."

Underdetection is another concern. Patients diagnosed as normal have been followed for a year by clinical investigators to ensure that CR mammography did not miss any cancers. Fuji executives believe all is in order.

"The data have been analyzed," Strauss said. "We are confident that we can answer any questions the FDA may have."

With these data scheduled for submission next month and the technical data already in, the ball will soon be in the FDA's court. The FDA must inspect Fuji facilities both in Japan and the U.S. to ensure that regulatory requirements about manufacturing and documentation are met.