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a. Traditional pathological examination of tissue samples remains the “gold standard” for evaluating tissue abnormalities and the presence of cancer. Optical Biopsy has been demonstrated to facilitate this traditional sampling and under certain conditions even potentially reduce the need for traditional examination.
b. The effectiveness of the Cellvizio system for assisting physicians in detecting cancer has not been evaluated by the U.S. FDA. These statements are not intended as claims of effectiveness or safety for these specific indications.
c. The Cellvizio Systems ability to help facilitate cancer detection is dependent upon the skill and experience of the physician using the system.