FDA clears NeuroMetrix's Universal electrodes for Advance system
This article was originally published in Clinica
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.
You may also be interested in...
Israel is well-known as a medtech hot-spot, with a focus on academic research and strong government support helping the country punch well above its weight when it comes to innovative devices.
St Jude Medical had a heavy focus on its intravascular imaging offering at this year’s EuroPCR meeting, presenting data supporting its optical coherence tomography (OCT) technology. OCT provides intravascular images to help assess culprit lesions, which can improve stent selection and deployment, according to St Jude.
A big topic at this year’s EuroPCR, held in Paris on 19-22 May, was drug-coated balloons (DCBs). One of the leaders in the field, Medtronic, presented positive data from two studies of its IN.PACT Admiral balloon, which could support an expanded indication for the device.