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.