1 May 2025
A speech project receives Breakthrough designation, the company says
Neuralink announced FDA Breakthrough Device designation for a project intended to assist communication in people with severe speech impairment. The designation alone did not establish that the device could be marketed or that its proposed benefits had been proven.
Sources and context
An attributed statement records what the speaker said.
- Speech Breakthrough Device designationCompany statement · Neuralink
- Breakthrough Devices ProgramRegulatory record · US Food and Drug Administration