CHICAGO - GE Medical Systems announced at this week’s RSNA meeting that it has already filed a premarket approval (PMA) application for its Senographe 2000D full-field digital mammography system. The Food and Drug Administration has granted the filing expedited review status, and will discuss the application at a committee meeting Dec. 16.
GE’s news tosses a bombshell into the jumbled race to get a full-field digital mammography system on the U.S. market. Mammography vendors have been forced to navigate a constantly changing regulatory process, with the FDA changing its regulatory position on digital mammography repeatedly.
The FDA originally told vendors that it would allow full-field digital mammography systems to go through the less-rigorous 510(k) process, with submissions supported by clinical trials comparing digital mammography to film-screen mammography. But problems ensued with that approach after reader variability made it difficult to make an apples-to-apples comparison of the two technologies.
One digital mammography firm, Trex Medical of Danbury, CT, got caught in a regulatory quagmire due to the FDA’s shifting position. After the company spent years trying to get its Trex Digital Mammography System through the 510(k) process, the FDA rejected its application this summer.
GE has apparently benefited from being the second company in line. The Waukesha, WI, vendor has been conducting clinical trials of Senographe 2000D, examining thousands of patients at multiple sites. The company filed its PMA on Oct. 29, according to Caren Mason, general manager of GE’s women’s healthcare business.
GE declined to provide many details about the FDA filing, citing the FDA’s review process. But entering the regulatory process with a PMA filing rather than a 510(k)-- usually seen as a disadvantage for a device company--could work to the firm’s benefit. Under the FDA’s system, 510(k) filings are used for devices that are "substantially equivalent" to something else on the market: Hence the FDA’s analog-to-digital comparison. PMAs are used for brand-new devices, giving GE the opportunity to start with a clean slate.
There’s no telling how long it will take before Senographe 2000D hits the U.S. market. PMAs typically take as long as two years to get approved, but the application’s expedited review will speed things up. The system could be approved as early as the second half of 2000.
Senographe 2000D received European approval earlier this year, and shipments started this summer. The system is being very well received in Europe, according to Amy Hobert, Americas marketing manager for breast imaging.
By Brian CaseyAuntMinnie.com staff writer
November 29, 1999
