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In Brief: Aksys

This article was originally published in The Gray Sheet

Executive Summary

Aksys: Investigational device exemption submission for the firm's PHD hemodialysis system is slated for submission in summer 1998, roughly nine months later than the firm previously had anticipated. In a June 6 release, the Lincolnshire, Illinois-based company says it will require additional time to "complete all performance specifications, validation and documentation requirements" for the device. Aksys maintains that the delay is "not a result of any technology or regulatory development," and does not reflect any "change in the feasibility of the product"...

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