Event
Neuralink receives FDA Breakthrough Device Designation for Blindsight
Key points
- Neuralink received FDA Breakthrough Device Designation for Blindsight.
- The visual prosthesis program is intended to restore visual perception for people with severe vision loss.
- The designation supports faster development and review but does not represent market approval.
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