# FDA Breakthrough Devices Program **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. ## Source route [[articles/2026 Annual Report on Brain-Computer Interfaces|2026 Annual Report on Brain-Computer Interfaces]] · [[collections/Neurotech|Neurotech]]