Neuralink wins FDA approval for its first human trial
Regulators cleared the company to test its brain implant in people.
Archive entry. This article looks back at an event from May 25, 2023. It was drafted with AI assistance from public records and is being fact-checked. See our About page.
On May 25, 2023, Neuralink said the US Food and Drug Administration had approved its application to begin its first clinical study in humans.
The company had reportedly sought approval earlier and been turned down, with regulators raising questions about the implant's battery, the risk of its wires migrating in the brain, and how the device could be removed safely.
Recruitment for the trial opened that fall, and the first participant received the implant in January 2024.
