Computerized Scanner Double-Checks Suspicious Mammograms – T-Scan 2000 – Brief Article
A new device will help radiologists determine whether a woman should be evaluated further when the results of her mammogram are unclear.
Approved by FDA in April, the T-Scan 2000 can potentially help identify women who should be referred for early biopsy and reduce the number of negative biopsies.
The T-Scan uses a hand-held scanner placed on the breast to evaluate certain suspicious areas detected on the mammogram. A computer connected to the scanner displays an image of the breast areas in question. The image is based on differences in the flow of electricity in malignant tumor tissue and surrounding normal tissue.
The T-Scan is intended as a follow-up to mammography, and does not replace mammography or other conventional methods of detecting or diagnosing breast cancer (such as clinical breast examination, ultrasound, or biopsy evaluation.)
Approval of the device was based on the results of three clinical studies of safety and effectiveness performed by the device’s manufacturer, TransScan Medical Inc., Ramsey, N.J., and on the recommendation of an advisory panel of outside experts.
As a condition of approval, TransScan Medical is required to conduct a postmarketing study on the effects of hormonal changes during the menstrual cycle on the device’s ability to detect and distinguish among breast abnormalities.
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