Paradromics, an Austin-based company, has received the FDA’s approval to start its early feasibility study (EFS) for the Connexus BCI system. This marks the first IDE approval for speech restoration with a fully implantable brain-computer interface (BCI).
The Connexus system aims to help patients who have lost the ability to speak and control computer devices, translating recorded brain signals into actionable health data. Initially focused on restoring independent communication through digital devices, it targets individuals living with spinal cord injuries, stroke, or ALS.
Following several milestones this year, including setting up investigators for the trial and demonstrating safe implantation of the BCI in a human subject, Paradromics is now ready to launch its clinical study. The company plans to enroll two participants who will undergo the study at three clinical sites: UC Davis, Massachusetts General Hospital, and the University of Michigan.
“This marks a new peak for neurotech development,” said Dr. Stephen Ryu, Paradromics’ Chief Medical Officer. “Our first human trial will allow us to demonstrate the unmatched performance, safety, and reliability of our high-bandwidth BCI to help overcome human limitations.”
The FDA’s approval is seen as a significant milestone in the BCI space, with analysts predicting a massive market opportunity for the technology.
Source: https://www.massdevice.com/paradromics-fda-green-light-bci-study