NeurAxis, Inc. announced on May 20, 2025, that it received FDA 510(k) clearance for its IB-Stim device for the treatment of Pediatric Functional Abdominal Pain (FAP)/Functional Dyspepsia (FD) and associated nausea symptoms. This marks the first-ever FDA clearance for this specific pediatric indication.
The clearance covers patients aged 8-21, aligning with the previously expanded age range for IB-Stim. This new indication significantly expands the total addressable market for IB-Stim, allowing the company to address a broader spectrum of chronic and debilitating conditions in children.
NeurAxis expects a seamless go-to-market strategy for this expanded indication, leveraging its existing reimbursement and provider infrastructure. This development is anticipated to drive further adoption and utilization of IB-Stim, contributing to the company's revenue growth and market penetration.
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