FDA allows Paradromics to recruit participants for its Connexus interface study across the US
Prepared by Sintelligent with the help of SI. Published in SI: . Updated: .
The study of a speech implant is moving from regional to nationwide recruitment of participants.
On October 26 Paradromics said the FDA has approved an amendment to the protocol of the Connect-One Early Feasibility Study: the requirement to live within a four-hour drive of a clinical site has been removed, and participants can come from anywhere in the US (they must be able to travel to the site). Connexus is a fully implantable wireless interface that records the activity of individual neurons and translates speech signals into digital communication. The study sites are UC Davis Health, Mass General Brigham and University of Michigan Health. The first long-term implantation took place at the University of Michigan in June 2026; according to the company, the recipient uses the device independently for synthesized speech, messages and calls. Lead investigator David Brandman (UC Davis Health): "Being able to recruit from anywhere in the continental U.S. is an important step in the field of brain-computer interfaces."
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