NeurAxis shared the FDA granted an expanded 510(k) clearance for its IB-Stim non-implanted nerve stimulator. IB-Stim delivers nerve stimulation for functional abdominal pain relief. The new indication expands the system’s addressable market and overall devices per patient, according to a news release.
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NeurAxis’ system utilises its proprietary percutaneous electrical nerve field stimulation (PENFS) technology. It has FDA clearance for functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents between 8-21 years old. The non-surgical device delivers gentle electrical impulses to cranial nerve bundles in the ear.
According to the company, no FDA-approved drug therapies exist for children with abdominal pain-related disorders of the gut-brain interaction. NeurAxis says pharmacologic treatments that use drugs off-label can lead to serious side effects. Additionally, the company says most of those therapies lack scientific evidence of efficacy.
President and CEO Brian Carrico said the company also received an expansion of payer coverage and a new reimbursement code. The American Medical Association assigned IB-Stim to CPT Category I, effective in January 2026. Carrico expects increased revenue and margin growth in the upcoming quarters following these developments.
“We are excited to receive this new 510(k) clearance for IB-Stim, which expands the IB-Stim addressable market by roughly 75%,” said Carrico. “Furthermore, we expect devices per patient to increase, as this new FDA clearance states on label use of four devices per patient. All of this has been achieved due to the strong body of published research, which has resulted in the increased acceptance of our PENFS technology.”
