NeurAxis, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for an expanded indication of IB-Stim™, a noninvasive neuromodulation device, for the treatment of pediatric functional abdominal pain associated with functional dyspepsia and related nausea symptoms in patients aged 8 to 21 years. This clearance is the first FDA authorization for a treatment specifically indicated for functional dyspepsia and broadens the labeled indication of IB-Stim.
IB-Stim was previously cleared for use in patients within the same age range for functional abdominal pain associated with irritable bowel syndrome. The expanded indication utilizes existing reimbursement structures, CPT coding, and provider call points to support an immediate and capital-efficient commercial rollout.
Brian Carrico, President and Chief Executive Officer of NeurAxis, stated that the approval represents a significant milestone in the company’s strategy, enabling broader clinical adoption while maintaining operational efficiency. The clearance is supported by clinical data on percutaneous electrical nerve field stimulation (PENFS), and the therapy continues to receive expanded insurance coverage. A new CPT Category I code for IB-Stim has also been approved by the American Medical Association and will take effect in January 2026.
According to Adrian Miranda, MD, Chief Medical Officer of NeurAxis, functional dyspepsia in adolescents often presents with abdominal pain and nausea that can result in secondary complications, including dietary restriction and weight loss. The device offers a nonpharmacologic treatment option in a population for whom effective and approved therapies are limited.
IB-Stim delivers low-frequency electrical impulses to cranial nerve branches in the ear and is currently the only FDA-cleared therapy for abdominal pain-related disorders of gut-brain interaction in pediatric patients. Pharmacologic options remain off-label and may carry risks of adverse effects with limited evidence of efficacy.
NeurAxis is conducting additional clinical trials to evaluate PENFS across other pediatric and adult populations with unmet medical needs. For information on contraindications, precautions, and instructions for use, refer to https://ibstim.com/important-information/.
Source: NeurAxis, Inc.
