TDMS clearance is first for a full-field digital mammography device
Once again, Europeans will be the first to gain access to cutting-edge technology developed in the U.S. for digital mammography. This time, the technology involved is a full-field digital mammography system manufactured by Trex Medical of Danbury, CT. Trex this month received the CE Mark for its TDMS (Trex Digital Mammography System), which gives the company the right to sell the device throughout the European Union.
In obtaining the CE Mark, Trex will become the first company to commercialize a modern full-field digital mammography system. The positive European decision, however, underscores the regulatory struggle that is still going on in the U.S., where the Food and Drug Administration has been reviewing a 510(k) application regarding TDMS for the past 10 months.
"I am disappointed that the FDA has not acted on us," said Hal Kirshner, president and CEO of Trex. "If it is good enough for Europe, it should be good enough for the U.S."
The European decision could turn up the heat on the FDA to clear the Trex device. The agency has lagged behind its European counterparts on other new mammography technologies. One such technology is computer-aided diagnosis workstations: In that case, the FDA took more than a year longer than the Europeans in approving a CAD workstation developed by R2 Technology of Los Altos, CA (SCAN 7/22/98).
Digital mammography has become a centerpiece of women's health in recent years, because of its promise to allow earlier detection of breast cancer. Several women's advocacy groups with considerable political clout on Capitol Hill, are actively following the Trex situation.
"You can believe that I will ask for their help, if I don't hear from the FDA soon," Kirshner said. "I am going to ask for the help of anyone who can get this important modality to market."
One advocacy group that might help is the National Alliance of Breast Cancer Organizations (NABCO). Amy Langer, executive director, believes digital mammography should be commercialized in the U.S. She does not, however, cast the FDA in a negative role. Instead, she said, the FDA is helping through cooperative efforts with other agencies within the Department of Health and Human Services (of which the FDA is a part) to advance the technology.
