NeurAxis (NRXS) Stock Skyrockets on First-Ever FDA Approval for GI Pain Device
Recent FDA Approval and Market Reaction NeurAxis’s Oct. 24, 2025 announcement of FDA 510(k) clearance for its PENFS device immediately grabbed market attention. The clearance authorizes use in adults (8 years and up) for functional abdominal pain associated with FD and nausea, a segment previously lacking any approved device treatment investing.com. Investing.com and other outlets confirm this milestone — noting it’s “the first FDA clearance or approval” for an adult FD treatment investing.com. In pre-market trading on Oct. 24, NRXS shares jumped (around +4% in early quotes) on the news, reflecting relief that FDA evidence support (from pediatric studies) could