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Paradromics announced on 17 June 2026 that University of Michigan surgeons have implanted its Connexus brain-computer interface in a woman with motor neuron disease, the first patient in the FDA-approved Connect-One early feasibility study. She will be followed for six years.
The Austin-based company is now enrolling participants at the University of Michigan and Massachusetts General Hospital for the Connect-One study, the first clinical trial of a fully implantable BCI designed to restore speech.
The agency's new policy ending the two-trial requirement was written for drugs, but brain implant makers watching Synchron, Neuralink, and Paradromics navigate FDA are asking whether the same logic could eventually ease their path.
The Austin-based neurotech company launches its APEX Partnership Program with five leading research institutions, aiming to push its Connexus brain-computer interface beyond speech restoration into stroke recovery, Parkinson's and motor rehabilitation.
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