SetPoint Medical Reports PMA Submission of SetPoint System to the US FDA for Treating Rheumatoid Arthritis
Shots:
- SetPoint Medical has submitted a PMA application to the FDA for its SetPoint System for treating adults with moderate-to-severe rheumatoid arthritis, who are incomplete responders or intolerant to biologic or targeted synthetic DMARDs
- The submission was based on results from the RESET-RA study, showing the system's potential as a safe and effective treatment for RA patients who are incomplete responders or intolerant to SoC
- The system consists of an implantable & rechargeable device to stimulate the vagus nerve, inducing anti-inflammatory pathways, for treating autoimmune conditions like RA. It is programmed for automatic stimulation to improve therapy adherence
Ref: SetPoint Medical | Image: SetPoint Medical
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
