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# FDA Approves SetPoint Medical Arthritis Device
- URL: https://www.fdaweb.com/fda-approves-setpoint-medical-arthritis-device/
- Published: 2025-07-31T12:00:00.000Z
- Updated: 2026-09-14T15:18:02.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159604

FDA has approved SetPoint Medical’s SetPoint System, a first-of-its-kind neuroimmune modulation device to treat adults with moderate to severe rheumatoid arthritis who are not adequately managed by, or can’t tolerate, existing advanced therapies such as biological and targeted synthetic disease-modifying anti-rheumatic drugs. A company [statement](https://www.businesswire.com/news/home/20250731334111/en/SetPoint-Medical-Receives-FDA-Approval-for-Novel-Neuroimmune-Modulation-Therapy-for-Rheumatoid-Arthritis?ref=fdaweb.com) says the approval was supported by the results of the 242-patient RESET-RA study that demonstrated the system’s safety and efficacy in the target population.

The SetPoint System is described as an implantable, integrated neurostimulation device designed to deliver electrical stimulation to the vagus nerve, once daily, to activate the body’s innate anti-inflammatory and immune-restorative pathways.