NURO - NeuroMetrix wins approval of neuromodulation device for fibromyalgia; shares up 42%

The U.S. FDA granted De Novo authorization to NeuroMetrix (NASDAQ:NURO) for its Quell neuromodulation device used to treat fibromyalgia. Shares are up 42% in premarket trading. Quell is the first non-pharmacological treatment for the condition approved by the agency. Quell is considered transcutaneous electrical nerve stimulation device. Data submitted by NeuroMetrix showed that in a subgroup analysis of subjects with high pain sensitivity, the Patient Global Impression of Change was 1.25 points higher in the treatment arm compared to the placebo arm.

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NeuroMetrix wins approval of neuromodulation device for fibromyalgia; shares up 42%