University of Michigan implants first-in-human Paradromics Connexus wireless BCI (Connect-One EFS)
First-in-human implant of the Paradromics Connexus wireless intracortical BCI (421 microelectrodes; chest transceiver; transcutaneous link) at University of Michigan on a woman with motor neuron disease, under the FDA-approved Connect-One EFS. >200 bits/sec info transfer in preclinical models; speech-first design.
Paradromics Connexus — First-in-Human Implant (Connect-One EFS)
Date: June 17, 2026 (implant in June 2026; announced via Michigan Medicine press release)
Site & surgeons: University of Michigan Health — neurosurgeons Matthew Willsey, M.D., Ph.D. and Aditya S. Pandey, M.D.
Participant: A woman from Michigan who struggles to speak due to motor neuron disease (ALS/PLS-class condition).
Fetch status: summary-derived — michiganmedicine.org returned HTTP 403 to WebFetch; the Paradromics IDE press release and NeuroscienceNews coverage fetched cleanly and corroborate every figure. Canonical Michigan Medicine URL preserved.
What happened
Paradromics, with the University of Michigan, completed the first-in-human implantation of its Connexus wireless brain-computer interface — the first patient in the FDA-approved Connect-One Early Feasibility Study (EFS). This is the clinical debut of the highest-bandwidth intracortical BCI to enter human trials, and the first fully-implantable system aimed specifically at speech restoration.
Device architecture (quoted)
- 421 microelectrodes — thinner than a human hair — that "capture brain signals from individual neurons."
- Signals travel to a small transceiver implanted in the user's chest, which sends data to an external receiver wirelessly through the skin (transcutaneous link), where AI processing runs.
- Information transfer rate: "200+ bits per second" in pre-clinical models — by Paradromics' measure, roughly 20× the Neuralink N1's reported rate and orders of magnitude beyond endovascular approaches.
Study design (quoted)
- Connect-One EFS initially enrolls two participants with "impaired speech and limited extremity movement (upper and lower) due to severe loss of voluntary motor control."
- Participants tracked for six years to assess long-term safety and whether the BCI can restore communication via synthesized text and speech and enable computer control.
- Clinical sites: UC Davis (Sacramento), Massachusetts General Hospital (Boston), University of Michigan (Ann Arbor).
Regulatory pathway
- FDA Investigational Device Exemption (IDE) granted November 20, 2025 — the first IDE approval for speech restoration with a fully implantable BCI.
- CEO Matt Angle: "In Q1 next year we are launching a clinical study with the best engineered brain computer interface in the world." (The first implant landed mid-2026.)
Significance
Paradromics moves from "FDA-cleared to start" (the Apr-2026 KB snapshot) to a patient implanted. The invasive-BCI clinical race is now genuinely three-way in humans — Neuralink, Synchron, and Paradromics — with Paradromics staking the high-bandwidth, speech-first corner of the design space.