# FDA Breakthrough Devices Program **Entity class:** Program or project **Type:** Regulatory program **Collection:** [[collections/Neurotech|Neurotech]] **Primary source:** [[articles/2026 Annual Report on Brain-Computer Interfaces|2026 Annual Report on Brain-Computer Interfaces]] ## Definition The FDA Breakthrough Devices Program is the regulatory designation named for Neuralink's Blindsight and speech-restoration applications. ## Relationships [[wiki/FDA Breakthrough Devices Program|FDA Breakthrough Device designation]] is related to [[wiki/Blindsight|Blindsight]], [[wiki/Neuralink|Neuralink]], and accelerated device review. <!-- BEGIN HUMANIZED RELATIONSHIPS 2026-09-11 --> This entry's documented connections are expressed in its definition and related-work routes, with provenance retained in the source-linked material. <!-- END HUMANIZED RELATIONSHIPS 2026-09-11 --> ## Source route [[articles/2026 Annual Report on Brain-Computer Interfaces|2026 Annual Report on Brain-Computer Interfaces]] · [[collections/Neurotech|Neurotech]] ## Related Work in the Corpus <!-- BEGIN HUMANIZED CORPUS ROUTES 2026-09-11 --> - In [[articles/2026 Annual Report on Brain-Computer Interfaces|2026 Annual Report on Brain-Computer Interfaces]], **Neuralink: Operational Clinical Program and Regulatory Trajectory** provides the narrative context for **FDA Breakthrough Devices Program**: Regulatory milestones include FDA Breakthrough Device Designation for Blindsight (September 2024)—Neuralink's visual cortex stimulation implant designed to restore vision in individuals who have lost both eyes or optic nerve… <!-- END HUMANIZED CORPUS ROUTES 2026-09-11 -->