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Just four months after filing a premarket approval application with the FDA, Fischer Imaging has received an approvable letter for its SenoScan full-field digital mammography system.Once final approval is received—Fischer executives hope as early
Just four months after filing a premarket approval application with the FDA, Fischer Imaging has received an approvable letter for its SenoScan full-field digital mammography system.
Once final approval is received-Fischer executives hope as early as this month-Fischer will join GE Medical Systems as the only manufacturers cleared by the FDA to market full-field digital mammography systems in the U.S. Final approval should come after the company meets two conditions, both of which may already have been met.
“The Office of Device Evaluation has completed its review, and approval is subject to completion of the manufacturing inspection and final product labeling,” said Ken Crocker, marketing manager for Fischer.
The final FDA write-up will be largely based on the inspection of Fischer’s manufacturing facility that occurred in mid-July.
“We feel pretty good about the results of that inspection,” Crocker said.
The inspection focused on Fischer’s quality assurance system, which had been questioned during a previous FDA visit. Crocker said only that those issues were minor ones and the company has remedied them. The FDA’s headquarters in Washington, DC, ultimately will issue the SenoScan PMA based upon recommendation from the agency’s Denver office.
The company’s PMA application was filed in March and included data from a three-year, 1500-patient study that compared results using the SenoScan with those achieved using conventional film-based mammography. The approvable letter indicated that the FDA found SenoScan to be safe and effective for use in the same clinical applications as traditional systems.
Although the FDA’s actual response to the Fischer application was quick, the agency and Fischer had been working together for several years to bring the system to market. Crocker described the relationship as an ongoing dialogue. All told, Fischer has invested some $30 million in the system, mostly for research and development and the six-site clinical trial.
At this point, Fischer need only sit tight, awaiting further word from the FDA regarding its application, as no response to the approvable letter is necessary. When final approval is granted, the company plans to begin marketing the product right away. Fischer is poised to begin shipping immediately after the PMA is granted. Crocker would not reveal sales projections for SenoScan, but he is optimistic that early demand will be strong.
Potential customers for the SenoScan include premier mammography providers, cutting-edge radiology groups, and integrated delivery networks. The system will sell for about $470,000. GE’s full-field digital system, Senographe 2000D, sells for under $450,000. GE claims the Senographe can image a woman in half the time of the Fischer system, but Crocker believes SenoScan has several advantages.
“We think its greater field-of-view, higher resolution, and lower dose compared with the GE system are advantages that customers will find important,” he said. “The field-of-view is particularly important. Until SenoScan, it really wasn’t possible for all women in the U.S. to appreciate the benefits of full-field digital.”
Crocker touted SenoScan’s field-of-view as nearly 50% greater than the GE system, but GE spokesperson Patrick Jarvis took issue with that statement.
“They’re claiming larger field-of-view with reduced dose, but I haven’t seen any documentation or published peer review studies confirming that,” he said.
Jarvis refused to say, however, that the statement was not accurate.
Crocker said SenoScan is highly dose-efficient compared with film-based mammography. The digital nature of the new system may help women more easily and quickly receive opinions from experts prior to undergoing more invasive procedures, such as biopsy, thanks to telemammography.
In addition to its claimed field-of-view, resolution, and dose benefits, the SenoScan has other benefits, Crocker said. Those include enhanced patient positioning and slot scanning architecture that minimizes scatter radiation and improves contrast. With slot scanning, which Jarvis called “old technology,” scatter radiation is reduced without attenuating the primary beam, according to Crocker.
SenoScan’s appeal may be further increased by a collaborative agreement between Fischer and CADx Medical Systems to integrate the CADx Second Look software into the digital mammography product. When the combination system will appear, however, is not known. The companies are collaborating on the development, integration, and regulatory approvals necessary for sale of both products in the U.S., Crocker said.
GE has an exclusive agreement to integrate R2 Technology’s computer-aided diagnostic program ImageChecker with its Senographe. The FDA has not yet cleared the combination.