TransScan works out PMA issues with FDA

Mammography firm TransScan Research and Development of Migdal Ha'Emek, Israel, and Ramsey, NJ, last month received a recommendation for premarket approval (PMA) from the Food and Drug Administration for its TransSpectral Impedance Scanning device, TS-2000. The agency's recommendation resolves a nonapprovable letter that TransScan received for the product last year (SCAN Special Report 12/97).

TS-2000 is a hand-held device used as an adjunct to mammography to detect breast cancer. The technology performs in real-time and transmits low-voltage electrical signals into body tissue, measuring changes in the signals to give information about the quality of tissue. TransScan began placing TS-2000 systems at beta sites in 1996 (SCAN 11/6/96).

TransScan's commercialization plans for TS-2000 hit a roadblock last November, however, after the FDA issued a nonapprovable letter asking the company to clarify the device's target population, as well as its effects on that population. After conducting additional targeted studies, TransScan submitted a revised PMA, which explained that TS-2000 will be used for patients with equivocal mammograms, the company said. TransScan estimates that each year TS-2000 could find between 6000 to 12,000 cancers that would be missed without it, and the device could eliminate as many as 350,000 biopsies per year.

The agency recommended the device for clearance contingent on TransScan conducting postmarket studies to define how patients' menstrual cycles affect the device's results. The company expects PMA clearance by the end of this month, according to John Neugebauer, TransScan's vice president of marketing. The company plans to price the device in a range between $45,000 and $55,000.

TransScan is still in negotiations with Siemens for a TS-2000 distribution deal in which Siemens would package the device with its mammography systems, Neugebauer said.