NeuroMetrix Gets FDA Breakthrough Device Tag for Fibromyalgia Treatment with Wearable Neurostimulation Tech

 NeuroMetrix, Inc. (Nasdaq: NURO) today announced that its Quell® device has received Breakthrough Designation from the U.S. Food and Drug Administration (FDA) for treating the symptoms of fibromyalgia in adults.

Fibromyalgia is a common form of chronic pain that is also accompanied by fatigue, sleep, cognitive and mood disturbances. It affects an estimated 2 to 6 percent of the U.S. population (5 to 15 million people) and is most often diagnosed between the ages of 30 and 50. The cause of fibromyalgia remains unclear, but scientific studies point to abnormalities in the way the brain processes normal sensations and pain. Although several drugs are FDA approved for managing fibromyalgia pain, there is an unmet need for safe and effective non-pharmacological treatments.

Quell is an advanced, non-invasive, nerve stimulation device that is covered by 18 U.S. utility patents. It is the only wearable neurostimulator that is enabled by a custom designed microchip that provides flexible, precise, high-power nerve stimulation in a form factor the size of a credit card. Quell utilizes position and motion sensing to automatically adjust stimulation for an optimal patient experience both day and night. The device supports Bluetooth® low energy (BLE) to communicate with the Quell app, which is available for iOS and Android mobile devices.

https://finance.yahoo.com/news/neurometrix-receives-fda-breakthrough-device-130000711.html