Initial evidence demonstrating the performance of ClearCut’s MRI technology in differentiating cancerous and non-cancerous breast tissue were gathered in a multi-center clinical study, performed in Israel.
The study was designed to characterize tissue samples taken from breast lumps immediately following excision. Each sample result was compared to histopathological analysis – the current gold standard for margin assessment. “Point to point” comparison of the MR measurements to the corresponding histopathology analysis concluded over 90% specificity and sensitivity.
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Investigational device. Limited by Federal (or United States) law to investigational use