FDA clears GE’s digital mammography system

Industry predictions proved correct last month when GE Medical Systems received premarket approval from the Food and Drug Administration for its full-field digital mammography unit, Senographe 2000D. The news made GE the first company to win the right to market a digital mammography system in the U.S.

GE received approval to market Senographe for hard-copy use only, and expects to list the unit at $500,000. The Waukesha, WI, firm will start selling the systems immediately, according to Charles Young, spokesperson. GE plans to hold a press conference in New York Feb. 23 to discuss details of Senographe’s technology, as well as the company’s estimated sales of the unit for the coming year.

The FDA’s approval of Senographe as a hard-copy device should work in GE’s favor, according to Young.

“We think there are many advantages to this (hard-copy-based approval),” he said. “Primarily, it will give clinicians time to become familiar with the technology. Although we think (soft-copy approval of Senographe) will be expedited, there are still productivity advantages that come with hard-copy, such as the elimination of films and processing chemicals.”

GE surprised industry observers at the December RSNA show with the announcement that it had submitted a PMA to the FDA on Oct. 29 (SCAN 10/13/99 and 1/12/00). At a public meeting Dec. 16, the FDA’s Radiological Devices Panel of the Medical Devices Advisory Committee advocated that the Office of Device Evaluation approve the system. The panel encouraged GE to submit a supplement for soft-copy use of Senographe and the FDA to expedite its review. GE is actively working on the soft-copy supplement to the PMA, according to Ed Basile, legal counsel to GE and senior partner at King & Spalding of Washington, DC. The committee also recommended that the FDA not require a nonenriched, postapproval screening trial, a suggestion the agency accepted, Basile said.

The panel’s recommendation proved persuasive, according to Robert Doyle, executive secretary of the Radiological Devices Panel and a scientific reviewer in the FDA’s radiology branch.

“The FDA thought (the panel’s) recommendation was well thought out, and that the technology shouldn’t be held up any more, especially since we’ve had so much input from the mammography community that the device works,” Doyle said.

GE’s victory in the race to commercialize digital mammography in the U.S. has come as a shock to an industry that has long been engaged in regulatory struggle over the technology with the FDA. Until last year, Trex Medical seemed to be the forerunner. But in August Trex received a letter from the agency rejecting its application (SCAN 8/18/99).

Despite this setback, Trex has continued to emphasize its commitment to digital mammography, and has begun collecting data for a PMA to be submitted later this year, according to William Webb, CEO. But Trex’s future took a surprising turn last month when it announced that its parent, Thermo Electron, has decided to exit the medical imaging business and will seek a buyer for Trex Medical as part of an overall strategy of focusing more closely on its measurement and detection instruments businesses (see story, front page). The news will have no effect on the progress of TDMS (Trex Digital Mammography System) to market, according to Webb.

GE praised the FDA’s handling of its application, but the agency’s overall approach still has critics in the clinical community. Among them is Dr. Daniel Kopans, director of breast imaging at Massachusetts General Hospital. Kopans affirmed that digital mammography brings key advantages to both clinicians and patients, but questioned whether the PMA was the best regulatory route.

“I’m pleased that the FDA has finally approved digital mammography. For those of us who have used digital it has been clear for quite some time that it is as good as if not better than conventional mammography,” Kopans said. “Certainly from the standpoint of reducing the need for retakes, image archiving and retrieval, telemammography, and CAD, it is clearly better. The only regret that I have in the FDA’s decision is that they should have approved it under the 510(k) mechanism. The premarket approval will make it much more difficult to improve the technology, since any alteration will require a complicated and expensive submission.”

The reaction of Denver-based Fischer Imaging’s chairman and CEO Morgan Nields to the clearance was similar to that of Kopans.

“(Manufacturers) have expressed a lot of concerns about the PMA,” Nields said. “But it’s positive that the FDA cleared the technology. Now customers can buy digital mammography units, and the (clinical community) can get more data from the machines. There are a lot of things that can begin now that a product has been cleared, such as establishing higher reimbursement levels.”

The FDA continues to emphasize that the 510(k) process is not out of the question for digital mammography developers, according to Doyle.

“We’ve made it clear that we have not closed off the 510(k) approach. Vendors can decide which route to take,” he said.

Even with the FDA’s approval of Senographe and built-up anticipation in the clinical community, GE still faces the challenge of selling an expensive system in a healthcare market that emphasizes cost-containment.

“It’s not clear how many of these devices will immediately appear on the market, due to their cost,” Doyle said. “But the price will probably come down once (the market) gets some competition.”