FDA clears NeuroMetrix's Universal electrodes for Advance system
This article was originally published in Clinica
Executive Summary
NeuroMetrix's Universal electrodes have received 510(k) clearance from the US FDA for use with the firm's Advance system for nerve conduction studies. The agency cleared three types of electrode: the Universal Stimulator Bar electrode for peripheral nerve stimulation; and the Universal Tab and Ring electrode sets for recording motor and sensory responses from these nerves. They are disposable, individually-placed electrodes not specifically configured for specific nerves or limbs. The Advance system received FDA 510(k) clearance in May 2008, and Waltham, Massachusetts-based NeuroMetrix CE marked it for sale in Europe in July.