GE resumes mammography shipments to U.S. after resolving GMP issue

December 18, 1996

Vendor shows full-field digital work at RSNA meetingGE Medical Systems has resumed U.S. deliveries of mammographysystems from its factory in Buc, France, after addressing theFood and Drug Administration's concerns about good

Vendor shows full-field digital work at RSNA meeting

GE Medical Systems has resumed U.S. deliveries of mammographysystems from its factory in Buc, France, after addressing theFood and Drug Administration's concerns about good manufacturingpractices at the facility. While the U.S. import suspension didresult in some lost sales for the Milwaukee vendor, the company'smammography business bounced back and is expected to finish theyear on budget, according to John Trani, president and CEO ofGEMS.

GE in June voluntarily halted shipments from Buc to the U.S.in response to an FDA inspection earlier in the year that foundfault with some of the facility's record-keeping and documentationprocedures (SCAN 7/17/96). GE's radiation therapy equipment manufacturedin Buc was also subject to the suspension.

GE addressed the FDA's complaints, and, after an FDA reinspectiongave the facility a clean bill of health, resumed U.S. shipmentsof mammography equipment in October, according to Trani. The Bucfactory's deliveries to international customers were not affectedby the suspension, which lasted less than three months.

Until Trex Medical brought mammography competitors Lorad andBennett X-Ray under its ownership, GE had the largest market sharein the modality. One would therefore expect the U.S. import suspensionto hurt the company's position, but Trani said it didn't takelong for the unit to return to fiscal health.

"We lost some sales, not a great deal," Trani said."When the detention was lifted a flood came over. We nowhave met all the backlog requirements, and we're right back towhere we were."

In fact, GE announced at this month's Radiological Societyof North America meeting that it expects this year to ship its15,000th mammography unit since the company entered the business.(The figure includes shipments made by Thomson-CGR, which GE boughtin 1987.) At its RSNA booth, GE featured the latest technologiesit is developing for breast imaging.

Perhaps the most promising new technology is digital mammography.As a work in progress, GE displayed SenoVision, a digital detectorfor spot imaging and stereotactic applications with an 8 x 8-cmfield-of-view. Like other spot digital units, SenoVision is basedon charge-coupled device technology.

SenoVision differs, however, in that it does not use fiber-opticreducers or lens coupling to link the phosphor plate to the CCDcamera. Instead, the plate is coupled with parallel fiber opticsdirectly to a large 8 x 8-cm CCD, allowing SenoVision to avoidimage quality loss and making the detector less bulky than otherCCD systems, according to Mona Theobald, manager of women's healthmarketing.

SenoVision's detector is about 0.5 inch thick, no thicker thana standard screen-film cassette, and will slip into the buckyof a Senographe DMR or Senographe 800T. GE has received 510(k)clearance for SenoVision and expects to begin shipping it in 1997.

GE also showed its work in developing a full-field digitalmammography system. Unlike SenoVision, this system will not useCCDs but rather will be based on flat-panel detector technologyusing amorphous silicon. This detector will also be very thinand will be marketed as an upgrade for Senographe DMR, which iswell suited for digital imaging, due to its rhodium anode tube,according to Theobald.

"Because you now have digital capture, you separate theimage capture from the image display, and I can manipulate myimages and my contrast independently of how I captured it,"Theobald said. "By utilizing the rhodium anode, I can gainthe penetration, I can minimize the mA and the time, so I havelower mAs, and I have lower dose to the patient."

Work on GE's full-field digital system is being conducted atGE's corporate R&D center in Schenectady, NY, and a systemis under evaluation at Massachusetts General Hospital in Bostonunder Dr. Daniel Kopans.