SetPoint Medical has received FDA approval for its neuroimmune modulation system, a first-of-its-kind implantable device that treats rheumatoid arthritis (RA) through daily vagus nerve stimulation.
Designed for adults who haven’t responded to conventional therapies like biologics or targeted DMARDs, the system activates the body’s natural anti-inflammatory pathways—offering a novel alternative to immunosuppressive drugs. Implanted during a simple outpatient procedure, it delivers therapy automatically on a preset schedule to ensure patient compliance.
Backed by data from its RESET-RA trial and supported by the FDA’s TAP program, the device could also be adapted for other autoimmune conditions like multiple sclerosis and Crohn’s disease.
A limited U.S. launch begins this year, with national rollout expected in early 2026.
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