NeurAxis Wins FDA Clearance for First Adult Functional Dyspepsia Pain Device

Reuters10-24

NeurAxis Wins FDA Clearance for First Adult Functional Dyspepsia Pain Device

NeurAxis Inc. has received FDA 510(k) clearance for its proprietary percutaneous electrical nerve field stimulation (PENFS) technology to treat functional abdominal pain associated with functional dyspepsia, including related nausea symptoms, in patients aged 8 years and older. This marks the first FDA clearance for a treatment targeting functional dyspepsia pain in adults. The expanded indication follows a review of clinical data supporting PENFS's safety and efficacy in younger patients, with the FDA extrapolating these findings to adult populations. The clearance significantly broadens NeurAxis's total addressable market and will allow use of the upcoming Category I CPT code for PENFS procedures starting January 1, 2026. No other organizations were mentioned as recipients of this regulatory approval.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. NeurAxis Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9551604-en) on October 24, 2025, and is solely responsible for the information contained therein.

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