TriPath submits PMA (premarket approval) supplement for screener:
This article was originally published in Clinica
TriPath Imaging is seeking a US premarket approval(PMA) supplement for permission to screen thin-layer specimens on its fully automated primary screening system. The PMA supplement provides clinical data that demonstrates the performance of the AutoPap system as a primary screener for slides produced by the AutoCyte PREP system, an automated liquid-based, thin-layer sample preparation system. The Burlington, North Carolina-based company, has been created through the merger of NeoPath and AutoCyte (see Clinica No 879, p 17). Both systems are already approved for sale in the US.
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