TransScan Medical, Inc.’s T-Scan TS-2000 breast imaging system was approved by the F.D.A. yesterday for use in cases where a mammogram has produced inconclusive results.
The device consists of a hand-held probe which is attached to a computer. The probe is placed on a patient’s breast and sends a small electrical signal through the breast tissue. That signal is used to distinguish between malignant and normal breast tissue. An image of the breast tissue is projected onto the computer monitor, where possible malignancies appear as bright spots.
TransScan boasts the fact that its device is non-invasive and radiation-free. The FDA has credited the T-Scan with the potential to reduce unnecessary biopsies and believes the device might also help to better identify women who are in need of biopsies.
The FDA stressed in a statement that the new T-Scan device is not meant to replace traditional breast cancer screening techniques, including breast self- and clinical exams, mammography, ultrasound, and biopsy evaluation.