FDA clears Paradromics implantable speech BCI trial
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The FDA granted Investigational Device Exemption to Austin-based Paradromics for its Connect-One Early Feasibility Study of the fully implantable Connexus brain–computer interface, aiming to restore speech in people with paralysis. The first two U.S. participants will receive a 7.5 mm electrode array in the motor cortex to decode neural activity into text or a synthesized voice, with the trial potentially expanding to 10 participants and testing cursor control via imagined hand movements.
FDA and Medical Devices
Brain–Computer Interfaces