FDA approves new device to clarify ambiguous mammogram results
April 19, 1999
WASHINGTON (CNN) -- The U.S. Food and Drug Administration approved a new device Monday that will help determine whether a woman with an unclear mammography will need a biopsy.
The device, called the T-Scan 2000, is not intended for use in patients with clear mammographies or those who have not had mammographies. It specifically helps doctors by adding another step before moving from a questionable mammography to a biopsy.
The T-Scan 2000 is a hand-held scan probe placed on the breast to evaluate certain suspicious areas detected on the mammogram. The probe is connected to a computer, which displays an image of those areas of the breast.
The T-Scan images are based on impedance, which is a measure of how any material can affect the flow of electricity. The images are based on differences in the electrical flow between malignant tumor tissue and the surrounding normal tissue.
The device measures the impedance by passing a small electrical signal through the body and displaying on a computer the result from sensors in the probe contacting the breast. The computer image contains bright spots where the impedance is consistent with a possible malignancy.
"The device has the potential to reduce the number of negative biopsies, thus saving women worry about breast lesions that turn out to be non-cancerous," the FDA said. "It also has the potential to increase the identification of women who should be referred for early biopsy."
The device is manufactured by TransScan Medical Inc. of Ramsey, New Jersey.
As a condition of approval, the FDA said that TransScan will be required to conduct a post-market 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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