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Medical Tactile introduces SureTouch breast mapping
By KAREN YOUNG Medical Device Daily Staff Writer
Medical Tactile (Los Angeles) is launching its SureTouch Visual Mapping System, a sensing device currently cleared only for documentation of clinical breast exam results, but that in about a year CEO Steve Weiss hopes ultimately will be FDA-approved for diagnostic screening of breast lesions.
The system was being shown at the 28th San Antonio Breast Cancer Symposium, beginning yesterday, and was being offered for commercial sale for documentation purposes only at this point.
?I don?t know for sure, because it?s up to the FDA when they review our request, but it could take probably in excess of a year [to get a PMA],? Weiss told Medical Device Daily.
He said he expects the FDA will require it to conduct clinical trials involving between 500 and 1,000 women.
Based on the company?s tactile sensing technology, the SureTouch Visual Mapping System uses sensors that are designed to detect lesions as small as 5 mm to improve the sensitivity, specificity and objectivity of manual breast palpation exams. The company said that such exams are the ?most accessible first line of defense? against breast cancer for most women.