Event
Neuralink receives FDA approval to launch first-in-human PRIME Study
Key points
- 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 is a neurotechnology company developing implantable brain-computer interfaces for people with unmet medical needs, beginning with device control for people with paralysis. Its system combines the N1 Implant, external software, wireless communication, and the R1 surgical robot used to place ultra-fine electrode threads in the brain.
Context
- Company
- Neuralink
- Segment
- Healthcare
- Event type
- Regulatory
- Geography
- Fremont · United States