FDA Approval


The FDA Pathology Devices Advisory Panel unanimously recommended that the FDA approve with conditions the supplement to the pre-market approval (PMA) submission to use the AutoPap System as a PRIMARY Pap Smear Screener. The PMA supplement requests approval to use the AutoPap System as an initial screener, identifying 25% of slides which receive AutoPap review only and may be archived as normal. The address pf NeoPath, Inc. is: 8271 - 154th Avenue NE, Redmond, Washington, 98052, USA. The website of NeoPath Corp. is: www.neopath.com