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Xillix Life-Lung postmarket reproducibility study required by FDA; device approved Sept. 20.

This article was originally published in The Gray Sheet

Executive Summary

XILLIX LIFE-LUNG POST-MARKET REPRODUCIBILITY STUDY is being required by FDA as a condition of its Sept. 20 approval of the endoscopic fluorescence imaging product for use in aiding the detection of abnormal bronchial tissue. The study, which will evaluate the consistency with which physicians can interpret fluorescent images produced by the device, will include 100 images to be evaluated by 30 physicians. Xillix is required to complete the study within two years, the firm says.
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