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In Brief: Neuromedical Systems, Inc.

This article was originally published in The Gray Sheet

Executive Summary

Neuromedical Systems, Inc.: Gains FDA approval Oct. 24 to promote its Papnet automated Pap smear reader as more effective than manual rescreening of negative slides. The supplemental approval allows NSI to claim that "Papnet testing of routine, presumed negative Pap smears, can be conservatively expected to identify at least 7.1 [times] more false negatives than manual re-examination of the same number of smears," the company says, adding that Papnet is "the only Pap smear testing method available...for which this claim can be made." Data supporting the supplemental approval came from a study of over 16,000 patients submitted to the agency in January...

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