Clinical Report: New Noninvasive Option for Functional Abdominal Pain

Overview

NeurAxis, Inc. has received FDA clearance for IB-Stim™, a noninvasive device for treating pediatric functional abdominal pain associated with functional dyspepsia. This marks the first FDA authorization specifically for functional dyspepsia in this age group.

Background

Functional abdominal pain, particularly in pediatric populations, can lead to complications such as dietary restrictions and weight loss. Traditional pharmacologic treatments may be off-label and carry risks of adverse effects. The introduction of IB-Stim provides a nonpharmacologic option for managing these conditions.

Data Highlights

No numerical data or trial data provided in the source material.

Key Findings

• IB-Stim is FDA-cleared for treating functional abdominal pain associated with functional dyspepsia in patients aged 8 to 21 years.
• The device previously received clearance for use in patients with functional abdominal pain related to irritable bowel syndrome.
• IB-Stim utilizes percutaneous electrical nerve field stimulation (PENFS) to deliver low-frequency electrical impulses.
• A new CPT Category I code for IB-Stim will take effect in January 2026, facilitating reimbursement.
• The device is currently the only FDA-cleared therapy for abdominal pain-related disorders of gut-brain interaction in pediatric patients.

Clinical Implications

The approval of IB-Stim offers healthcare providers a new noninvasive treatment option for adolescents suffering from functional abdominal pain.

Conclusion

The FDA clearance of IB-Stim represents a new treatment option for functional abdominal pain in pediatric patients.

Related Resources & Content

1. NeurAxis, Inc., NeurAxis Press Release, 2023 -- New Noninvasive Option for Functional Abdominal Pain
2. Pain Medicine — Evaluation of a novel nerve ablation technique to relieve lower back pain: a cadaveric feasibility pilot study
3. conexiant — Ultrasound Brain Stimulation Eases Chronic Pain
4. BJS (British Journal of Surgery) — Understanding Postoperative Ileus
5. Exploring Present and Future Approaches to Managing Chronic Pain Associated with Inflammatory Bowel Disease
6. FDA Product Classification for IB-Stim
7. ESPGHAN/NASPGHAN Guidelines for Pediatric IBS
8. https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250451.pdf
9. https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252024.pdf
10. Device Classification Under Section 513(f)(2)(De Novo)
11. Rome V: A Global Framework for Disorders of Gut–Brain Interaction | The Rome Foundation
12. Neurostimulation for abdominal pain-related functional gastrointestinal disorders in adolescents: a randomised, double-blind, sham-controlled trial - ScienceDirect
13. Efficacy of Auricular Neurostimulation in Adolescents With Irritable Bowel Syndrome in a Randomized, Double-Blind Trial - PubMed
14. Cardiac Vagal Efficiency Is Enhanced by Percutaneous Auricular Neurostimulation in Adolescents With Nausea: Moderation by Antidepressant Drug Exposure - Kolacz - 2025 - Neurogastroenterology & Motility - Wiley Online Library