Paradromics and University of Michigan Complete First Connexus BCI Implantation for FDA-Approved Connect-One Clinical Study
Summary
Paradromics Inc. announced the completion of the first surgical implantation of its Connexus brain-computer interface at University of Michigan Health. The procedure was performed by Dr. Matthew Willsey on a woman with motor neuron disease who has difficulty speaking. The Connect-One Early Feasibility Study will evaluate long-term use of the Connexus BCI to restore speech and enable computer control for people with severe motor impairment. Following FDA approval of an IDE in November 2025, clinical teams at Michigan, UC Davis, and Massachusetts General Hospital began screening participants.
Why it matters
This represents a major milestone for high-data-rate BCIs moving from laboratory research into rigorous clinical evaluation. The six-year study will provide critical long-term safety and efficacy data for intracortical BCIs, potentially establishing a new standard for communication restoration in ALS and other severe motor impairments.
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