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, Inc. (NRXS)
Company Research
Source: GlobeNewswire
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, 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
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- NeurAxis Secures Veterans Affairs Federal Supply Schedule Contract, Broadening Access to More Patients with Functional Abdominal Pain [Yahoo! Finance]Yahoo! Finance
- NeurAxis Secures Veterans Affairs Federal Supply Schedule Contract, Broadening Access to More Patients with Functional Abdominal PainGlobeNewswire
- NeurAxis Announces New Medical Policy Coverage in Michigan, Adding 566,000 Covered LivesGlobeNewswire
- NeurAxis Reports Strong Third Quarter 2025 Financial Results Driven by a 22% Growth in RevenuesGlobeNewswire
- NeurAxis to Host Third Quarter 2025 Results and Business Update Call on Tuesday, November 11, 2025GlobeNewswire
NRXS
Sec Filings
- 11/12/25 - Form SCHEDULE
- 11/10/25 - Form 10-Q
- 10/24/25 - Form 8-K
- NRXS's page on the SEC website