Paradromics

A workshop at the BCI Society Meeting 2025, run with the Implantable BCI Collaborative Community (iBCI-CC), took up how clinical outcome assessments (COAs) for pivotal BCI trials should be selected, developed and validated. Participants pointed to patient heterogeneity, the absence of widely validated COAs, and the difficulty of capturing outcomes that matter in home and daily-life settings. The discussion lays groundwork for the iBCI-CC Clinical Study Endpoints Workgroup to build a transparent process for identifying meaningful aspects of health and concepts of interest, in support of regulatory approval and reimbursement.

Surgeons in Michigan have implanted Paradromics' Connexus brain-computer interface in a patient with motor neuron disease who had lost most of her ability to speak. Connexus records from individual neurons through 421 microelectrodes seated 1.5 millimeters into the motor cortex; the signals pass to a transceiver in the patient's chest, where AI converts them into text on a screen. Austin, Texas-based Paradromics received FDA approval in the fall of 2025 to begin the clinical trial.