Business

NeurAxis Awarded First Ever FDA Clearance for the Treatment of Pain in Functional Dyspepsia (FD) with associated Nausea Symptoms in the Adult Patient Population

Achieves significant expansion of NeurAxis’ total addressable marketClearance now includes patients aged “8 years and older”Expanded age indication will utilize the upcoming January 1st, 2026, Category I CPT code to report PENFS procedures CARMEL, Ind., Oct. 24, 2025 (GLOBE NEWSWIRE) -- NeurAxis, Inc. (“NeurAxis,” or the “Company”) (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies addressing chronic and debilitating conditions in children and adults, t

articleNeuraxis, Inc.October 24, 20254/company/neuraxis-inc/news/neuraxis-awarded-first-ever-fda-clearance-for-the-treatment-of-pain-in-functional-dyspepsia-fd-with-associated-nausea-symptoms-in-the-adult-patient-population
NeurAxis Awarded First Ever FDA Clearance for the Treatment of Pain in Functional Dyspepsia (FD) with associated Nausea Symptoms in the Adult Patient Population

About this update from Neuraxis, Inc.

[{"type":"image","alt":"NeurAxis, Inc.","displaySize":"","headline":null,"caption":"NeurAxis, Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":89,"url":"https://media.zenfs.com/en/globenewswire.com/53c594c0241aa2985511c98a9154c355"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/26D4nWOeQUW1.Tx0Xl.qeg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTEyNTtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/53c594c0241aa2985511c98a9154c355","width":300,"height":89}},"lazy":false},{"type":"list","items":[{"val":[{"type":"text","content":"Achieves significant expansion of NeurAxis’ total addressable market","length":68,"tagName":"p"}]},{"val":[{"type":"text","content":"Clearance now includes patients aged “8 years and older”","length":56,"tagName":"p"}]},{"val":[{"type":"text","content":"Expanded age indication will utilize the upcoming January 1st, 2026, Category I CPT code to report PENFS procedures","length":115,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":239,"olType":false},{"type":"text","content":"CARMEL, Ind., Oct. 24, 2025 (GLOBE NEWSWIRE) -- NeurAxis, Inc. (“NeurAxis,” or the “Company”) (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies addressing chronic and debilitating conditions in children and adults, today 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 (FAP) associated with functional dyspepsia (FD), 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.","length":1136,"tagName":"p"},{"type":"text","content":"“This latest FDA clearance represents a pivotal milestone for NeurAxis as it is the first ever FDA approved or cleared treatment in the...

More updates from Neuraxis, Inc.

functional dyspepsiaFDANeurAxisnausea symptomsForward-Looking StatementsCompanyFDtechnologyapproved drug therapies