Neuralink receives FDA approval to launch first-in-human PRIME Study
Evidence notes
- Neuralink received FDA approval in May 2023 to launch its first-in-human PRIME Study.
- The study evaluates the safety and initial effectiveness of the N1 Implant and R1 surgical robot system for people with paralysis.
- The approval moved Neuralink from preclinical development into human clinical testing for its implantable brain-computer interface.
Company context
Neuralink develops implantable brain-computer interfaces and the R1 surgical robot used to place ultra-fine electrode threads.