NeuroMetrix Submits De Novo Application to FDA for Treatment of Symptoms of Fibromyalgia with Quell
(RTTNews) – NeuroMetrix Inc. (NURO) said it has submitted a De Novo application to the United States Food and Drug Administration for a Quell wearable neuromodulation device as a prescription treatment for fibromyalgia symptoms in patients. adult. The company received breakthrough designation from the FDA for this indication in July.
NURO closed Wednesday’s regular trading at $ 8.62 down $ 0.76 or 8.10%. But in after-hours trading, the stock gained $ 1.23 or 14.27%.
The company hopes to commercially launch Quell for this indication in the second half of 2022.
Fibromyalgia is chronic pain that is accompanied by fatigue, sleep, cognitive and mood disturbances. The cause of fibromyalgia remains unclear, but scientific studies indicate abnormalities in the way the brain processes normal pain and sensation. There are currently no medical devices with FDA clearance or approval for the treatment of fibromyalgia.
The De Novo route for marketing authorization is available for low to moderate risk medical devices that do not have an authorized predicate device and are therefore not eligible for the pre-marketing notification process. market (i.e. 510 (k)).
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