TransScan wins additional FDA clearance

Mammography firm TransScan Research and Development has received clearance from the Food and Drug Administration for a premarket approval supplement for its TS-2000 electrical impedance breast scanning system that covers improvements in the unit’s design and operation. The Ramsey, NJ, firm announced the news along with Siemens Medical Systems of Iselin, NJ, with which it signed a marketing agreement last December (SCAN 1/7/99).

A hand-held device that measures electrical impedance in breast tissue, TS-2000 includes a ground-electrode cylinder that patients hold as it transmits a low-voltage electrical signal through the body. A probe placed on the breast and moved across the skin measures changes in the signal. In real-time, the probe produces images on a computer screen that reveal differences in the electrical impedance between malignant tumor tissue and normal tissue.

The unit was initially cleared by the FDA in April for use as an adjunct to mammography for follow-up exams in patients with equivocal mammograms (SCAN 4/28/99). TransScan hopes that the cleared PMA supplement will pave the way for the unit to be used for other types of cancer.