NeurAxis Inc. Secures FDA Clearance for IB-Stim to Treat Pediatric Functional Dyspepsia and Associated Nausea, Expanding Market Reach

Reuters

2025/05/20

NeurAxis Inc. Secures FDA Clearance for IB-Stim to Treat Pediatric Functional Dyspepsia and Associated Nausea, Expanding Market Reach

CARMEL, Ind., May 20, 2025 - NeurAxis, Inc., a medical technology company, has announced it has received FDA 510(k) clearance for its IB-Stim™ device to treat Pediatric Functional Abdominal Pain (FAP) associated with Functional Dyspepsia, and related nausea symptoms in patients aged 8 to 21 years. This marks a significant achievement as it is the first treatment ever cleared by the FDA for functional dyspepsia, expanding IB-Stim's total addressable market significantly. The clearance, which follows the device's initial approval for Functional Abdominal Pain associated with Irritable Bowel Syndrome (IBS), further solidifies NeurAxis' leadership in non-invasive, pediatric-focused neuromodulation. The company's President and CEO, Brian Carrico, highlighted the strategic importance of this milestone, emphasizing the potential for substantial revenue growth and increased insurance coverage. The American Medical Association's recent approval of a new CPT Category I code for IB-Stim, effective January 2026, is expected to support this expansion.

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: GNW9454793-en) on May 20, 2025, and is solely responsible for the information contained therein.

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Secures FDA Clearance for IB-Stim to Treat Pediatric Functional Dyspepsia and Associated Nausea, Expanding Market Reach","media":"Reuters","content":"<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      NeurAxis Inc. Secures FDA Clearance for IB-Stim to Treat Pediatric Functional Dyspepsia and Associated Nausea, Expanding Market Reach\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        CARMEL, Ind., May 20, 2025 - NeurAxis, Inc., a medical technology company, has announced it has received FDA 510(k) clearance for its IB-Stim™ device to treat Pediatric Functional Abdominal Pain (FAP) associated with Functional Dyspepsia, and related nausea symptoms in patients aged 8 to 21 years. 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Secures FDA Clearance for IB-Stim to Treat Pediatric Functional Dyspepsia and Associated Nausea, Expanding Market Reach\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1032215980\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Reuters </p>\n<p class=\"h-time\">2025-05-20 20:00</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      NeurAxis Inc. Secures FDA Clearance for IB-Stim to Treat Pediatric Functional Dyspepsia and Associated Nausea, Expanding Market Reach\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        CARMEL, Ind., May 20, 2025 - NeurAxis, Inc., a medical technology company, has announced it has received FDA 510(k) clearance for its IB-Stim™ device to treat Pediatric Functional Abdominal Pain (FAP) associated with Functional Dyspepsia, and related nausea symptoms in patients aged 8 to 21 years. This marks a significant achievement as it is the first treatment ever cleared by the FDA for functional dyspepsia, expanding IB-Stim's total addressable market significantly. The clearance, which follows the device's initial approval for Functional Abdominal Pain associated with Irritable Bowel Syndrome (IBS), further solidifies NeurAxis' leadership in non-invasive, pediatric-focused neuromodulation. The company's President and CEO, Brian Carrico, highlighted the strategic importance of this milestone, emphasizing the potential for substantial revenue growth and increased insurance coverage. The American Medical Association's recent approval of a new CPT Category I code for IB-Stim, effective January 2026, is expected to support this expansion.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<em>Disclaimer: <span>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. 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Secures FDA Clearance for IB-Stim to Treat Pediatric Functional Dyspepsia and Associated Nausea, Expanding Market Reach. Disclaimer: This news brief was created by Public Technologies  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  on May 20, 2025, and is solely responsible for the information contained therein.","collect":0,"end_time":0,"defaultTopTitle":"","property":["earning"],"viewcount":null,"language":"en","relate_stocks":{"NDAQ":"纳斯达克OMX交易所","NRXS":"Neuraxis, Inc."},"translate_title":"NeurAxis Inc.获得FDA批准IB-Stim治疗儿科功能性消化不良和相关恶心，扩大市场范围","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"NRXS":0.9,"NDAQ":0.9},"content_text":"NeurAxis Inc. Secures FDA Clearance for IB-Stim to Treat Pediatric Functional Dyspepsia and Associated Nausea, Expanding Market Reach\n    \n\n        CARMEL, Ind., May 20, 2025 - NeurAxis, Inc., a medical technology company, has announced it has received FDA 510(k) clearance for its IB-Stim™ device to treat Pediatric Functional Abdominal Pain (FAP) associated with Functional Dyspepsia, and related nausea symptoms in patients aged 8 to 21 years. This marks a significant achievement as it is the first treatment ever cleared by the FDA for functional dyspepsia, expanding IB-Stim's total addressable market significantly. The clearance, which follows the device's initial approval for Functional Abdominal Pain associated with Irritable Bowel Syndrome (IBS), further solidifies NeurAxis' leadership in non-invasive, pediatric-focused neuromodulation. 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