17 Sep 2024
Blindsight receives a development designation, according to Neuralink
Neuralink announced FDA Breakthrough Device designation for its Blindsight project for people with vision impairment. The FDA explains that designation helps accelerate development and review, while separate safety and effectiveness standards still apply to marketing authorisation.
Sources and context
An attributed statement records what the speaker said.
- Blindsight Breakthrough Device designationCompany statement · Neuralink
- Breakthrough Devices ProgramRegulatory record · US Food and Drug Administration