CARMEL, Ind., May 20, 2025 - NeurAxis, Inc., a medical technology company, has announced it has received FDA 510(k) clearance for its IB-Stim™ device to treat Pediatric Functional Abdominal Pain (FAP) associated with Functional Dyspepsia, and related nausea symptoms in patients aged 8 to 21 years. This marks a significant achievement as it is the first treatment ever cleared by the FDA for functional dyspepsia, expanding IB-Stim's total addressable market significantly. The clearance, which follows the device's initial approval for Functional Abdominal Pain associated with Irritable Bowel Syndrome (IBS), further solidifies NeurAxis' leadership in non-invasive, pediatric-focused neuromodulation. The company's President and CEO, Brian Carrico, highlighted the strategic importance of this milestone, emphasizing the potential for substantial revenue growth and increased insurance coverage. The American Medical Association's recent approval of a new CPT Category I code for IB-Stim, effective January 2026, is expected to support this expansion.
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