TransScan wins FDA clearance for T-Scan 2000 breast imaging device

Siemens to sell device as mammography adjunct

After a lengthy and at times uncertain regulatory process, mammography firm TransScan Research and Development of Migdal Ha’Emek, Israel, received good news this month when the Food and Drug Administration cleared its novel breast imaging device for marketing in the U.S. The news puts the company on firm footing as it seeks to expand the product’s future applications.

TransScan won clearance April 19 for T-Scan 2000, a hand-held device that measures electrical impedance in the body in order to detect breast cancer. T-Scan 2000 is intended to be used as an adjunct to mammography for follow-up exams for patients with equivocal mammograms, and the company hopes the device will reduce the number of negative biopsies performed.

T-Scan 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.

TransScan’s path to approval has been challenging. The company began placing systems at beta sites in 1996 (SCAN 11/6/96). It submitted a premarket approval application in July 1997, but the PMA was rejected five months later when the company received a not-approvable letter from the FDA. TransScan submitted a revised PMA application and last August the FDA recommended approval for the device, contingent on the company’s conducting postmarket studies to address how patients’ menstrual cycles affect T-Scan 2000’s results (SCAN 9/2/98).

With clearance in hand, TransScan can move forward in commercializing the unit with its marketing partner, Siemens Medical Systems of Iselin, NJ. The two firms signed an agreement just before last year’s RSNA meeting that gave Siemens exclusive rights to sell T-Scan 2000 to worldwide hospital markets, with the exception of Korea, Italy, and Israel, where TransScan will market directly (SCAN Special Report 1/99). TransScan plans to market the device itself to non-hospital facilities, and expects to list T-Scan 2000 at about $50,000.

In the future, TransScan would like to expand T-Scan 2000’s applications, and will seek approvals for clinical uses of T-Scan 2000 technology with other types of cancer, according to the company.

“This is a platform technology,” said Carl Alfarano, chief financial officer. “Mammography is the first application, but we’d like to use the overall platform to expand T-Scan 2000’s uses to such applications as skin cancer, prostate cancer, and cancer of the lymph nodes.”