# FDA Investigational Device Exemption **Entity class:** Concept or analytic term **Type:** Regulatory pathway **Collection:** [[collections/Neurotech|Neurotech]] **Primary source:** [[articles/2026 Annual Report on Brain-Computer Interfaces|2026 Annual Report on Brain-Computer Interfaces]] ## Definition An Investigational Device Exemption is the FDA pathway named in connection with Paradromics' 2025 clinical authorization. ## Relationships [[wiki/FDA Investigational Device Exemption|Investigational Device Exemption]] is related to [[wiki/Paradromics|Paradromics]] and [[wiki/Connexus Direct Data Interface|Connexus Direct Data Interface]] through clinical investigation authorization. <!-- 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 Investigational Device Exemption**: The broader BCI sector has attracted substantial capital attention, with Morgan Stanley projecting the market at \$400 billion by 2025 driven by accessibility integrations and therapeutic applications—a valuation envelope that… <!-- END HUMANIZED CORPUS ROUTES 2026-09-11 -->