Neuraxis received FDA 510k clearance for PENFS technology

NeurAxis (NRXS) announced that it has received FDA 510(k) clearance for its proprietary percutaneous electrical nerve field stimulation, PENFS, technology for the treatment of functional abdominal pain associated with functional dyspepsia, and FD related nausea symptoms, in patients aged 8 years and older. The FDA reviewed the clinical literature supporting the use of NeurAxis’ PENFS technology, including randomized controlled trials and real-world evidence demonstrating the device’s safety and effectiveness in pediatric patients and individuals up to 21 years of age. Based on this comprehensive review, the FDA extrapolated the data to adults, supporting the use of PENFS in patients aged 8 years and older. This expanded indication marks a historic milestone, the first FDA clearance or approval for a treatment specifically addressing functional dyspepsia in adults.