Paradromics Receives FDA Approval to Expand BCI Access to Personal Computing Devices in Connect-One™ Clinical StudyParadromics Inc., a leader in neurotechnology and developer of the world’s highest-data-rate brain-computer interface platform, today announced that it has received an approval letter from the U.S. Food and Drug Administration (FDA) expanding the types of computing devices that may be used with its investigational BCI system. The approval creates a pathway for Paradromics to support compatible personal, internet-connected devices through Convey™, its user-facing system for translating decoded neural intent into communication and computer control.
Paradromics Appoints William J. Marks, Jr., MD, MS-HCM, as Chief Clinical Officer
Paradromics Inc., a leader in neurotechnology and developer of the world’s highest-data-rate brain-computer interface platform to restore human function and advance human capability, today announced the appointment of William J. Marks, Jr., MD, MS-HCM, as Chief Clinical Officer. Dr. Marks is a neurologist and clinical scientist with nearly three decades of experience across clinical neuroscience, implantable medical devices, neuromodulation, and digital health.
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.
