NeuroMetrix maintains an active R&D program. Our strategy is to develop unique, proprietary medical devices that utilize non-invasive neurostimulation to diagnose and treat neurological conditions and pain. We seek to define new product categories and leapfrog existing technology. We develop products using our specialized in-house 10-person R&D team.
- Second generation device currently under development.
- Commercial launch expected Q4 2021 – Q1 2022
Quell® is currently indicated for symptomatic relief and management of chronic lower extremity pain. We are seeking to expand the FDA authorized clinical indications to include a number of chronic pain and neurological conditions with high prevalence and unmet treatment needs.
- Quell has been granted Breakthrough Device Designation by the FDA for treatment of fibromyalgia symptoms in adults (read more)
- RCT examining efficacy of Quell in fibromyalgia has been published in the Journal of Pain Research (read more)
- De Novo submission expected Q4 2021
- Potential commercial launch in H2 2022
- Chemotherapy Induced Peripheral Neuropathy (CIPN)
- Pilot study evaluating effectiveness of Quell in CIPN has been published in Supportive Care in Cancer (read more)
- NIH funded multi-center RCT is currently ongoing (read more), potential readout H1 2022
- Restless Leg Syndrome (RLS)
The use of Quell for fibromyalgia, CIPN and RLS is investigational only. The safety and effectiveness for these purposes has not been reviewed by the United States Food and Drug Administration (FDA).