Why Are NeuroMetrix Shares Shining In Thursday Premarket?

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.