SetPoint Medical Accepted into FDA Total Product Life Cycle Advisory Program for Development of its Neuroimmune Modulation Platform for the Treatment of Multiple Sclerosis
SetPoint Medical , a clinical-stage healthcare company dedicated to patients with chronic autoimmune diseases, announced that it has been accepted into the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot from the U.S. Food and Drug Administration (FDA) for the development of its novel neuroimmune modulation platform for people living with relapsing-remitting multiple sclerosis (RRMS).
- SetPoint Medical , a clinical-stage healthcare company dedicated to patients with chronic autoimmune diseases, announced that it has been accepted into the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot from the U.S. Food and Drug Administration (FDA) for the development of its novel neuroimmune modulation platform for people living with relapsing-remitting multiple sclerosis (RRMS).
- The FDA’s Center for Devices and Radiological Health (CDRH) launched the TAP Pilot to help expedite development and patient access to safe and effective high-quality medical devices upon FDA approval.
- In October 2023, the FDA expanded the program to include neurological and physical medicine devices.
- SetPoint's integrated neurostimulation device uses precise vagus nerve stimulation to activate innate anti-inflammatory and immune-restorative pathways to treat autoimmune conditions.