BETA
Implantable neuroimmune modulation for rheumatoid arthritis, with additional investigational autoimmune programs.
SetPoint Medical develops implantable neuroimmune modulation technology. Its system stimulates the vagus nerve to engage pathways involved in inflammatory regulation, with an approved rheumatoid arthritis indication and separate clinical development programs.
FDA approved the SetPoint System through PMA in July 2025 for selected adults with moderately to severely active rheumatoid arthritis after inadequate response, loss of response or intolerance to specified disease-modifying drugs. The original PMA has supplements, so current labeling must be checked for individual treatment decisions.
The company is led by Murthy Simhambhatla and is building commercial access, clinical support and manufacturing capabilities. Its multiple-sclerosis study remains investigational and does not extend the rheumatoid arthritis approval to MS.
SetPoint System received original PMA approval P240039 on July 30, 2025 for specified adults with moderately to severely active rheumatoid arthritis after inadequate response, loss of response or intolerance to one or more biological or targeted synthetic DMARDs. Multiple-sclerosis use remains investigational despite IDE permission and development designations. [18][21][19][5][15][1]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [6][3]
Latest recorded source review: 2026-10-20.
Documented commercial product families.
Vagus nerve stimulation for the specifically approved rheumatoid arthritis population. [18][21]
FDA PMA approvedCommercially offered; exact model and country availability should be confirmed with the manufacturer.
RA is commercial under its approved label; MS remains investigational. [18][21][19]
Pilot clinical evaluation of neuroimmune modulation in MS. [19]
Investigational / in developmentInvestigational only; not commercially available.
Company announced enrollment in the investigational MS pilot. [19]
Original U.S. approval of SetPoint System for specified adult rheumatoid arthritis patients. [21]
Accessed 10/29/2026