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# NeuroMetrix ‘Breakthough’ on Fibromyalgia Device
- URL: https://www.fdaweb.com/neurometrix-breakthough-on-fibromyalgia-device/
- Published: 2021-07-20T12:00:00.000Z
- Updated: 2026-09-14T17:06:58.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149745

FDA has granted NeuroMetrix a breakthrough designation for its Quell device and its use in treating the symptoms of fibromyalgia in adults. Quell is a wearable nerve stimulation device that provides nerve stimulation to treat fibromyalgia-related pain.

The designation was based on data from a double-blind, randomized, sham-controlled trial (NCT03714425). A total of 119 subjects with fibromyalgia were enrolled and randomized to a standard (active) or modified (sham) Quell device for three-months, the company says. “In an intention-to-treat (ITT) analysis of all subjects, 56% of those on active treatment exhibited a clinically meaningful improvement in health-related quality-of-life (Fibromyalgia Impact Questionnaire, FIQR) compared to 35% that received sham treatment,” it says. “There were additional positive outcomes in both the ITT population and in a pre-specified subgroup analysis of subjects with elevated pain sensitivity based on Quantitative Sensory Testing (QST).”

Currently, the over-the-counter device is indicated for symptomatic relief and management of chronic lower extremity (knee, foot and leg) pain.