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news.Medical device company NeuroMetrix has received FDA 510(k) clearance for its Advance System. This regulatory determination by the FDA gives NeuroMetrix clearance to market Advance in the US market.
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Advance is a comprehensive platform for the performance of traditional nerve conduction studies and invasive electromyography procedures. The device is intended to be used by physicians to perform nerve conduction studies and invasive electromyography procedures.
Shai Gozani, NeuroMetrix’s president and CEO, said: “Advance builds on our extensive experience developing, manufacturing, and marketing neurophysiological technologies. We believe that the technological and clinical features of Advance , its overall cost, and the exceptional customer and technical support provided by NeuroMetrix will be attractive compared to the other devices in this market segment.”