Neurosurgeons at University of Michigan Health last Wednesday carried out the first-in-human implantation of Paradromics’ fully implantable Connexus brain-computer interface in a Michigan woman who lost the ability to speak because of motor neuron disease. The operation was led by Dr. Matthew Willsey, a neurosurgeon and biomedical engineer who started his career as an electrical engineer. According to the team, the surgery involved a craniotomy to place a high-density cortical array and a small chest incision to position the device’s transceiver, and the participant will be followed for six years under the Connect-One early-feasibility study.
What the Connexus system is built to do
Paradromics describes Connexus as a high-channel-count, fully implantable brain-computer interface that relies on 421 microelectrodes to capture single-neuron activity and send that data to a discreet transceiver under the skin. The company says the system is designed to decode speech-related brain signals and ultimately restore communication and computer control for people with severe motor impairment.
How the surgery was performed
Willsey outlined the operation as a familiar neurosurgical workflow, starting with the incision and craniotomy, followed by opening the dura, placing and inserting the cortical array, securing the lead, then making a small chest incision for the transceiver. He told Business Insider that the procedure itself takes about four hours. The team confirmed that the electrodes were successfully communicating before closing, and Willsey said that, for experienced neurosurgeons, most steps felt routine.
First-in-human surgery at U-M
University of Michigan Health reported that the implant took place at U-M and marked the site’s first implantation for the FDA-approved Connect-One Early Feasibility Study. The participant is expected to return regularly for follow-up visits and testing over a six-year period. Michigan Medicine added that the trial will evaluate whether a fully implantable BCI can restore synthesized speech and dependable computer control.
How Connexus fits into the BCI race
Paradromics obtained an Investigational Device Exemption from the FDA in November 2025 to launch the Connect-One study, and the company framed the U-M procedure as the first formal step in a larger multi-site effort. The move situates Paradromics alongside other high-profile implant programs, including Neuralink’s PRIME trials, which reported a first human implant, and Synchron’s Stentrode, which has reported encouraging 12-month safety and performance data, as covered by MassDevice.
What comes next for the patient and clinic
According to Michigan Medicine, the study team will keep a close eye on the participant through clinic visits, speech-decoding tests, and ongoing motor-neuron care at U‑M’s Stanford Morris ALS Clinic, tracking safety and signal stability over time. Looking ahead, Willsey told Business Insider that the operation is not that technically different from a surgical standpoint and that the goal is to make the procedure repeatable if the data ultimately support it.
