FDA approves Paradromics IDE for Connect-One BCI trial — speech restoration as primary endpoint
Summary
Paradromics received FDA Investigational Device Exemption approval in November 2025 to begin the Connect-One early feasibility study evaluating the Connexus high-bandwidth implantable BCI for speech restoration and computer control in severe paralysis. Uniquely, Connect-One is designed around speech restoration as a primary endpoint — not just cursor control — placing Paradromics in direct competition with Neuralink on the most clinically meaningful BCI benchmark.
Why it matters
FDA IDE approval for Paradromics means three cortical BCI companies — Neuralink, Precision Neuroscience, and Paradromics — now have active US clinical programs simultaneously. The speech-first primary endpoint is strategically differentiated from Neuralink's cursor/typing approach and directly addresses the most urgent unmet need for ALS patients.
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