StoryRegulatory
FDA grants Premarket Approval (PMA) for SetPoint System, the first neuroimmune-modulation device for rheumatoid arthritis
SetPoint MedicalSetPoint System
The FDA approved the SetPoint System for adults with moderate-to-severe rheumatoid arthritis refractory to or intolerant of biologic or targeted synthetic disease-modifying drugs. The approval marks the first regulatory authorization of an implanted neuroimmune-modulation therapy for any autoimmune disease.