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# De Novo Sought for Fibromyalgia Neuromodulator
- URL: https://www.fdaweb.com/de-novo-sought-for-fibromyalgia-neuromodulator/
- Published: 2021-10-07T12:00:00.000Z
- Updated: 2026-09-14T17:18:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150323

NeuroMetrix has filed a de novo request for its Quell wearable neuromodulation device for treating symptoms of fibromyalgia in adults. The company received an FDA breakthrough designation for this indication in July.

The submission is based on data from a double-blind, randomized, sham-controlled trial (NCT03714425) involving 119 patients with fibromyalgia, the company says. “In an intention-to-treat (ITT) analysis of all randomized subjects, 57% of those on active treatment exhibited a clinically meaningful improvement in health-related quality-of-life (Fibromyalgia Impact Questionnaire, FIQR) compared to 34% that received sham treatment (p=0.014),” it says. “Subjects in the active treatment arm reported statistically significant improvements in 19 of the 21 symptoms comprising the FIQR instrument, including pain, sleep, fatigue, balance and the ability to carry out typical daily activities.”

Quell is designed to provide precise, high-power nerve stimulation. It uses position and motion sensing to automatically adjust stimulation, according to the company.