Applications

The chronic human trial of the Paradromics Connexus BCI: FDA IDE approval in November 2025, first implant at University of Michigan Health announced 17 June 2026, targeting speech restoration and computer control.

Application — Intracortical

Paradromics Connexus, Connect-One study

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Paradromics · Connexus · speech · early feasibility study · IDE · wireless · human · company

Device

Lab or organization

Paradromics Connexus, Connect-One study

One-line verdict: The step after the acute implant. Connexus moves from a temporary placement during epilepsy surgery to a chronic implant in a person with motor neuron disease.

Quick tags: Recording · Intracortical · Human · First implant announced 17 June 2026

Overview

What it is: The Connect-One Early Feasibility Study of the Connexus brain-computer interface. Per the sponsor, the study will evaluate long-term use of the device to safely restore speech and enable computer control for people with severe motor impairment.

How the device is described: A high-density microelectrode array records neural signals and sends them to a discrete transceiver in the chest, which transmits wirelessly through the skin to an external receiver. The sponsor says the micro-electrodes are each thinner than a human hair and that materials include titanium and platinum-iridium.

Timeline: FDA granted an Investigational Device Exemption in November 2025. University of Michigan, UC Davis and Massachusetts General Hospital then began screening. The first participant, a woman in Michigan with difficulty speaking from motor neuron disease, was implanted at University of Michigan Health by Matthew Willsey and colleagues, and is to be followed for six years. The study initially enrolls two participants.

Earlier step: The first temporary Connexus implantation was done at U-M Health in 2025 during epilepsy research. See the acute first-in-human entry.

What is not shown yet: No participant results are cited here. The 200+ bits per second figure the company quotes is from a preclinical preprint, not from this study.

Spec Card Grid

Identity

  • Sponsor: Paradromics Inc., Austin, Texas
  • Study: Connect-One Early Feasibility Study (NCT07357428)
  • Lead principal investigator: David M. Brandman, UC Davis
  • Sites: University of Michigan, UC Davis, Massachusetts General Hospital

Architecture

  • Sensor: high-density microelectrode array, intracortical
  • Link: chest transceiver, wireless through the skin to an external receiver
  • Electrode count and dimensions: not given in the sources used here

Evidence and limits

  • Status: investigational use only
  • No 3D model yet: published geometry is not in the sources used here

References