> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# NeuroMetrix De Novo Authorization for Fibromyalgia
- URL: https://www.fdaweb.com/neurometrix-de-novo-authorization-for-fibromyalgia/
- Published: 2022-05-23T12:00:00.000Z
- Updated: 2026-09-14T17:45:37.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151877

FDA has granted NeuroMetrix a de novo authorization to market its Quell neuromodulation device as an aid for reducing fibromyalgia symptoms in adults with high pain sensitivity. The authorization was supported by data from a randomized, sham-controlled trial in 119 subjects with fibromyalgia. “In a pre-specified subgroup analysis of subjects with high pain sensitivity (N=60), Patient Global Impression of Change (PGIC) was 1.25 (95% CI \[0.25, 2.24\]) points higher in the active arm compared to the sham arm (p=0.015),” the company says. PGIC was the primary study outcome measure and represents a treated patient’s overall assessment of treatment efficacy on a seven-point categorical scale, it says. In an intent-to-treat analysis of all randomized subjects (N=119), 57% of those on active treatment exhibited a clinically meaningful improvement in health-related quality-of-life compared to 34% that received sham treatment.