Paradromics completes first-in-human temporary Connexus implant at University of Michigan

Paradromics/Connexus BCI

During a routine epilepsy resection at University of Michigan Health, surgeons inserted Paradromics' Connexus array temporarily, recorded brain signals, and removed it intact in under 20 minutes. The procedure, the first in-human use of the device, validated that the brain-computer interface works as designed after three years of preclinical development.

• Device implanted and removed in under 20 minutes during scheduled brain surgery, demonstrating technical feasibility and safety.
• Connexus later received two FDA Breakthrough Device designations: one for restoring communication to people unable to speak and another for restoring motor control.
• Paradromics received FDA Investigational Device Exemption in 2024 for Connect-One early feasibility study, the first IDE approval for speech restoration with a fully implantable BCI.