This article was originally published in The Gray Sheet
Executive SummaryProteomics-based cancer diagnostic firm announces 510(k) filing April 29 for NMP22 BladderChek, the point-of-care version of the company's FDA-approved NMP22 laboratory test kit. The device is intended for use in physician offices in conjunction with cystoscopy, the primary clinical procedure used by urologists to visually identify bladder tumors. Following FDA clearance, Endocare will be responsible for U.S. product distribution...
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