second FDA Breakthrough Device Designation

# second FDA Breakthrough Device Designation **Entity class:** Concept or analytic term **Collections:** [[collections/Neurotech|Neurotech]] · [[collections/Consciousness Continuity|Consciousness Continuity]] ## Definition **second FDA Breakthrough Device Designation** is a concept or analytic term. [[wiki/CorTec Brain Interchange|CorTec Brain Interchange]] is associated with **second FDA Breakthrough Device Designation**. Aug 31 2026; communication/cursor control in non-progressive quadriplegia. The entry centers on the concept's meaning, practical use, and boundaries, together with the examples that make the distinction operational rather than merely verbal. ## Relationships  This entry is routed through [[collections/Neurotech|Neurotech]] and [[collections/Consciousness Continuity|Consciousness Continuity]]. Its source context is developed in [[articles/2026 Annual Report on Brain-Computer Interfaces|2026 Annual Report on Brain-Computer Interfaces]] and [[articles/Technologies for Consciousness Mapping and Transfer|Technologies for Consciousness Mapping and Transfer]]. Status-qualified source edges are preserved in the terminal Research Edges section. ### Key Relationships - [[wiki/CorTec Brain Interchange|CorTec Brain Interchange]] is associated with **second FDA Breakthrough Device Designation**. Aug 31 2026; communication/cursor control in non-progressive quadriplegia.  ## Research Edges  #### Consciousness mapping and transfer graph patch — 2026-09-10 **Collections:** [[collections/Neurotech|Neurotech]] · [[collections/Consciousness Continuity|Consciousness Continuity]] **Relationship source:** [[research/Consciousness Mapping and Transfer Ecosystem Relationship Graph - 2026-09-10|Consciousness Mapping and Transfer Ecosystem Relationship Graph — 2026-09-10]] **Related source articles:** [[articles/Technologies for Consciousness Mapping and Transfer|Technologies for Consciousness Mapping and Transfer]] · [[articles/The Architecture of Continuity and Emerging Neuroinformatics Standards|The Architecture of Continuity and Emerging Neuroinformatics Standards]] · [[articles/2026 Annual Report on Brain-Computer Interfaces|2026 Annual Report on Brain-Computer Interfaces]] · [[articles/The Organic-Synthetic Brain Atlas|The Organic-Synthetic Brain Atlas]] #### Incoming typed edges - **Edge 756 — [[wiki/CorTec Brain Interchange|CorTec Brain Interchange]] `received` → this entry** — **VERIFIED_COMPANY_REGULATORY_REPORT**; evidence `CORTEC_2ND_BREAKTHROUGH`. Aug 31 2026; communication/cursor control in non-progressive quadriplegia.