Neuralink receives FDA approval for its first-in-human clinical study

Neuralink/N1 implant (Telepathy)

Neuralink announced FDA approval for the PRIME first-in-human clinical study of its brain implant on May 25, 2023. The company said it was not yet recruiting participants and would announce more details later.

• FDA approval granted for first-in-human clinical study
• Study not yet recruiting at time of announcement
• Follows earlier FDA rejection in early 2022 over safety concerns including battery and wire migration
• Approval enables the company to move toward human trials