FDA clears IRIS's (International Remote Imaging Systems) urinalysis system:
This article was originally published in Clinica
Executive Summary
International Remote Imaging Systems (IRIS) has received FDA 510(k) clearance to market its automated 939UDx urine pathology system in the US. Chatsworth, California-based IRIS claimed that the product is the first "full-walkaway" system that can perform complete urinalysis profiles with automatic reporting of microscopic sediment results for most specimens. The system, which was launched at the beginning of May, integrates the Roche Hitachi Chemstrip Super UA urine analyser for urine test strip chemistries with IRIS's imaging flow cytometer and a high-resolution image display station.