Askys completes daily dialysis clinical trial:
This article was originally published in Clinica
Executive Summary
Aksys appears to be on track with its plan for submitting a 510(k) clearance application for its Personal Hemodialysis (PHD) system to the US FDA later this year, following the completion of a 25-patient clinical trial of the device. The number of treatments performed using the PHD system during the trial was equal to over 13 years of conventional three times per week dialysis, including over ten years of conventional treatment at home, said the Lincolnshire, Illinois company.
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