Paradromics and University of Michigan Complete First Connexus® BCI Implantation for the FDA-Approved Connect-One Clinical Study
Paradromics Inc., a neurotechnology company that has developed the highest data-rate brain-computer interface (BCI) platform, announced today the completion of the first surgical implantation in the FDA-approved Connect-One Early Feasibility Study (EFS) at University of Michigan Health. The procedure was performed by Matthew Willsey, M.D., Ph.D., a neurosurgeon and biomedical engineer, with Aditya S. Pandey, M.D., and a multidisciplinary team of providers.
Paradromics Receives FDA Approval for the Connect-One Clinical Study with the Connexus® Brain-Computer Interface
Paradromics Inc., a neurotechnology company developing the highest data-rate brain-computer interface (BCI) platform, today announced the US FDA has granted Investigational Device Exemption (IDE) approval to begin the Connect-One Early Feasibility Study (EFS) with the Connexus BCI. As the first company to receive IDE approval for speech restoration with a fully implantable BCI, Paradromics is excited to give participants the opportunity to control a computer and communicate via text or synthesized speech to recover connection.
