StoryRegulatory
Synchron receives FDA IDE approval to begin US trial of the Stentrode
The FDA granted Synchron an Investigational Device Exemption to test its Stentrode motor neuroprosthesis in people with paralysis, ahead of Neuralink. The device is delivered through the jugular vein into vessels on the brain's surface.
- First FDA IDE approval for endovascular brain-computer interface
- Stentrode delivered minimally invasively through jugular vein
- Approves patient recruitment for COMMAND clinical trial
- $10M NIH grant awarded to support the trial