FDA let a brain-implant speech trial recruit across the whole country

The FDA approved Paradromics to expand nationwide recruitment for its Connect-One Early Feasibility Study of Connexus, a fully implantable wireless brain-computer interface that records individual neurons and translates speech-related signals into text, a digital voice or device commands.

The approval removes a rule that participants live within a four-hour drive of a study site in Sacramento, Boston or Ann Arbor. The first participant, implanted in June, is a Michigan woman with a progressive motor neuron disease who now uses the system to choose her own words, answer open-ended questions and speak with her grandchildren by phone.

“Being able to recruit from anywhere in the continental U.S. is an important step in the field of brain-computer interfaces,” said lead investigator Dr. David Brandman of UC Davis Health. The device remains investigational under an FDA exemption granted in November 2025.