Connexus
Paradromics' fully implanted intracortical brain-computer interface, with 421 microelectrodes, in the FDA-approved Connect-One early feasibility study for speech restoration and computer control. The first participant, implanted in June 2026, was speaking her own words in real time by September.
Overview
Connexus is the implant system of Paradromics. A dime-sized array of 421 platinum-iridium microwires penetrates the cortex, as the Utah array does, with a different electrode design. A lead runs under the skin to a power and data unit implanted in the chest, which transmits wirelessly through intact skin to an external receiver.
Clinical status
The FDA approved an Investigational Device Exemption for the Connect-One early feasibility study on 20 November 2025. The study evaluates speech restoration and computer control for people with severe motor impairment, follows each participant for six years, and runs at University of Michigan Health, UC Davis Health and Mass General Brigham.
The first implant took place at University of Michigan Health on 17 June 2026, in a woman in her 60s with motor neurone disease. Surgeons placed the array in the part of the precentral gyrus that controls the muscles of speech. An FDA approval announced on 26 August lets compatible personal laptops, tablets and phones be added to the study without per-device approval, and a second participant had been identified by then. By 14 September the first participant was choosing her own words and speaking them in real time through text and synthesised speech, including a live phone call with her grandchildren.
Why it matters
Connexus puts a company-built system into the speech-restoration field alongside the academic programmes at UC Davis, UCSF and Stanford (see speech BCI). The September demonstration came without words per minute, word-error rate or vocabulary size, so it cannot yet be set against published academic benchmarks. Peer-reviewed performance data and the pace of enrolment beyond the first participant are the next tests of whether the platform can support a pivotal trial.
Coverage on InsideBCI
- 16 September 2026: Paradromics’s first Connexus participant used a brain implant to speak her own words
- 26 August 2026: Paradromics wins FDA approval to connect its Connexus BCI to personal laptops, tablets and phones inside Connect-One
- 17 June 2026: A Michigan woman with motor neuron disease has received the first Paradromics Connexus brain implant
- 31 March 2026: Paradromics Begins Recruiting Patients for Connexus Speech-Restoration Trial