Related Experiment Video

Updated: Oct 29, 2026

A Randomized, Sham-Controlled Trial of Cranial Electrical Stimulation for Fibromyalgia Pain and Physical Function, Using Brain Imaging Biomarkers
08:33

A Randomized, Sham-Controlled Trial of Cranial Electrical Stimulation for Fibromyalgia Pain and Physical Function, Using Brain Imaging Biomarkers

Published on: January 5, 2024

Post-approval modification of high-risk chronic pain devices approved through the FDA premarket approval pathway,

Bassel Almarie1, Ygor Nascimento Junqueira2, Mustafa Dodurgali3

  • 1Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.

Expert Review of Medical Devices
|October 28, 2026
PubMed
Abstract

Keywords:
Chronic painmedical device recallsmedical devicespostmarket surveillancepremarket approvalspinal cord stimulation

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