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NEOPATH AUTOPAP AUTOMATED PAP SMEAR ANALYZER RECOMMENDED FOR PRIMARY SCREENING; DEVICE SUPERIOR TO MANUAL REVIEW IN DETECTING ABNORMALITIES

This article was originally published in The Gray Sheet

Executive Summary

Additional data submitted as part of NeoPath's premarket approval application supplement for use of the AutoPap automated cervical cytology reader as a primary screener of Pap smear slides are adequate to support approval, FDA's Hematology and Pathology Devices panel unanimously (8-0) recommended at a Jan. 28 meeting in Rockville, Maryland. The panel said the PMA for the device, which would identify certain slides as not requiring a manual evaluation, should be approved with conditions.
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