NeuroMetrix, Inc. To Launch First FDA-Approved Medical Device for Fibromyalgia
Novel medical device and technology company, NeuroMetrix, Inc. (Nasdaq: NURO), will launch the first and only medical device authorized by the FDA to help reduce the symptoms of fibromyalgia.
The full commercial launch of the company’s Quell® Fibromyalgia device is expected to take place in Q2 2023. A Pathfinder Program will be launched on 1 December 2022 to validate and further refine the commercial process.
- 25 key opinion leaders in fibromyalgia practice across the United States will be involved in the company’s Pathfinder Program.
- The Program will enable NeuroMetrix to clarify its messaging and distribution process to increase market access to its technology.
- Quell Fibromyalgia is a wearable neuromodulator enabled by a proprietary microchip to provide precise, high-power nerve stimulation in a form factor the size of a credit card.
- NeuroMetrix’s Quell technology is covered by 23 U.S. utility patents.
NeuroMetrix’s device is a transcutaneous electrical nerve stimulation (TENS) device indicated as an aid for reducing the symptoms of fibromyalgia in adults with high pain sensitivity. It can be used during sleep.