Goldman Sachs expects Nvidia ’beat and raise,’ lifts price target to $240
Investing.com -- Neuraxis Inc (NASDAQ:NRIX) stock gained 4.2% in premarket trading Friday after the company received FDA clearance for its nerve stimulation technology to treat functional abdominal pain.
The U.S. Food and Drug Administration granted 510(k) clearance for Neuraxis’s proprietary percutaneous electrical nerve field stimulation (PENFS) technology. The treatment is approved for functional abdominal pain associated with functional dyspepsia, and related nausea symptoms, in patients aged 8 years and older.
This marks the first FDA clearance specifically addressing functional dyspepsia in the adult patient population. The regulatory decision was based on clinical literature supporting the technology’s use, including randomized controlled trials and real-world evidence demonstrating safety and effectiveness.
The FDA initially reviewed data from pediatric patients and individuals up to 21 years of age, then extrapolated these findings to support use in adults. The expanded indication allows Neuraxis to target a broader patient population with its PENFS technology.
Functional dyspepsia is a common digestive disorder characterized by pain or discomfort in the upper abdomen, often accompanied by symptoms such as nausea, bloating, and early satiety.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.