Aksys to begin trial of first dialysis product:
This article was originally published in Clinica
Executive Summary
Aksys has been given the go-ahead by the US FDA to begin trials of its personal haemodialysis system (PHD), the company's first product. The Lincolnshire, Illinois-based firm had filed its investigational device exemption in March, but the FDA had asked for validation of its software. Once the trial is complete, Aksys plans to submit a 510(k) clearance application before the third quarter of next year.
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