Why Are NeuroMetrix Shares Shining In Thursday Premarket?

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  • NeuroMetrix Inc NURO submitted a De Novo request to the FDA for Quell as a prescription treatment for fibromyalgia symptoms in adults. 
  • The Company received FDA Breakthrough Designation for this indication in July.
  • Related: NeuroMetrix Stock Skyrockets On FDA Update: Technical Levels To Watch.
  • The De Novo pathway for marketing authorization is available to low-to-moderate risk medical devices that do not have a cleared predicate device and are therefore not eligible for the 510(k) process.
  • Related: NeuroMetrix's Nerve Stimulator Shows Mixed Outcomes In Fibromyalgia Trial.
  • Quell is a wearable neuromodulator enabled by a proprietary microchip that provides precise, high-power nerve stimulation in a form factor the size of a credit card. 
  • Quell utilizes position and motion sensing to adjust stimulation automatically. 
  • Related content: Benzinga's Full FDA Calendar.
  • Price Action: NURO stock is up 16.40% at $10.03 during the premarket session on the last check Thursday.
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