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Siemens AG and TransScan Medical have signed an extension of their agreement allowing Siemens to market the TS2000 breast scanning system, which has two FDA clearances for use as an adjunct to mammography.Under terms of the multiyear agreement, Siemens
Siemens AG and TransScan Medical have signed an extension of their agreement allowing Siemens to market the TS2000 breast scanning system, which has two FDA clearances for use as an adjunct to mammography.
Under terms of the multiyear agreement, Siemens has exclusive rights everywhere but in Israel and the U.S. The new agreement also significantly expands its markets beyond the hospital segment to include clinics, breast centers, and physicians offices. In the U.S., TransScan will distribute the TS2000 through direct sales and independent dealers.
TransScans TS2000, its TransSpectral Impedance Scanning device, is a hand-held unit that measures electrical impedance in breast tissue and includes a ground-electrode cylinder that patients hold as it transmits a low-voltage electrical signal through the body (SCAN 1/12/00). A probe placed on the breast and moved across the skin measures changes in the signal. The probe produces images on a computer screen that reveal differences in the electrical impedance between normal tissue and malignant tumor tissue.
The unit was initially cleared by the FDA in April 1999 for use in follow-up exams for patients with equivocal mammograms (SCAN 4/28/99). In November 1999, TransScan won clearance from the FDA for a PMA supplement that covers improvements in TS2000s design and operation.
The Ramsey, NJ, company signed the initial marketing agreement with Siemens in November 1998 (SCAN 1/7/99). TransScans TS3000 is a work-in-progress next-generation scanner that it hopes will be able to capture the entire breast with one image. The company is also planning to develop T-Scan for other applications, including skin cancer, thyroid, and liver imaging, and to develop lymph node and biopsy probes for the unit.