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news.NeuroMetrix, a medical device company, has received the FDA 510(k) clearance for its Universal Electrodes. This regulatory determination by the FDA gives NeuroMetrix clearance to market the Universal Electrodes in the US.
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NeuroMetrix has obtained regulatory clearance for three Universal Electrodes – the Universal Stimulator Bar Electrode for peripheral nerve stimulation, and the Universal Tab and Ring Electrode Sets for recording of motor and sensory responses from peripheral nerves.
The Universal Electrodes are individually placed electrodes which are not configured for specific nerves or limbs. They are disposable and for single patient use. These electrodes are intended to be used with the NeuroMetrix Advance NCS/EMG System for performance of nerve conduction studies.
Shai Gozani, NeuroMetrix’s president and CEO, said: “The Universal Electrodes represent an important expansion of our consumables offering for physicians using Advance. These electrodes allow physicians to stimulate and record from essentially any peripheral nerve at both distal and proximal sites.
“We believe these electrodes will be used by neurologists, physical medicine and rehabilitation physicians, and other specialists with peripheral nerve expertise that have adopted our Advance System.”