Paradromics, a neurotechnology company developing brain-computer interfaces to restore and enhance human capabilities, today announced that the FDA has approved an amendment to the protocol for its Connect-One Early Feasibility Study, removing the requirement that prospective participants live within a four-hour drive of a participating clinical site.
Connexus BCI is a fully implantable, wireless brain-computer interface that records activity from individual neurons and translates intended speech into digital communication. Paradromics began human clinical trials of Connexus this year, completing its first long-term human implantation at University of Michigan Health in June 2026. Its first participant is now using the BCI to communicate independently through synthesized speech, send text messages, and make phone calls.
The authorization enables eligible individuals from across the United States to be considered for participation regardless of where they reside. Under the revised protocol, participants must be able to travel to a study clinical site for required study activities, and individuals who receive primary care elsewhere must be willing to confirm their primary-care clinician’s contact information to facilitate applicable coordination of care. All other eligibility requirements remain in effect.
The Connect-One study brings together three leading U.S. academic medical centers with expertise in neurosurgery, neurological disorders, and brain-computer interface research. Participating clinical sites include UC Davis Health in Sacramento, California, with David M. Brandman, MD, PhD, lead principal investigator for the study; Mass General Brigham, in Boston, Massachusetts, with Daniel B. Rubin, MD, PhD; and University of Michigan Health in Ann Arbor, Michigan, with Matthew Willsey, MD, PhD.
Paradromics is working with investigators to determine how participants traveling significant distances can be appropriately supported during screening, study visits, long-term follow-up, and coordination with local clinical teams.
Authorized under an FDA Investigational Device Exemption in November 2025, Connect-One is evaluating the long-term safety and performance of Connexus in people with severe motor impairment. Its initial clinical focus is restoring communication, while the study is also helping establish the clinical practices and long-term care procedures needed to support intracortical BCIs.
By expanding the population that may be considered for Connect-One, Paradromics and its clinical partners are taking another step toward establishing the evidence, clinical practices, and patient support systems needed to make high-performance BCI technology accessible to more people.
