Paradromics Inc., a neurotechnology company developing the highest data-rate brain-computer interface (BCI) platform, has announced a significant milestone with the US FDA granting Investigational Device Exemption (IDE) approval to initiate the Connect-One Early Feasibility Study (EFS) using its Connexus BCI.

This is the first IDE approval granted for speech restoration with a fully implantable BCI, a device engineered to record and decode brain signals at unprecedented rates of information transfer, having previously demonstrated an industry-leading 200+ bits per second in preclinical models.

The Connect-One Study, which Paradromics' CEO called "the best engineered brain computer interface in the world," will launch in the first quarter of next year and initially enroll two participants who have severely impaired speech and limited movement due to loss of voluntary motor control, giving them the ability to communicate via text or synthesized speech.

The fully implantable Connexus BCI uses hair-thin micro-electrodes to capture individual neuron activity, with the signals traveling to a compact chest-implanted receiver that wirelessly transmits data to an external computer using AI for translation. The EFS will be conducted across three clinical sites—UC Davis, Massachusetts General Hospital, and the University of Michigan—and is a crucial step in demonstrating the high-bandwidth BCI's performance, safety, and reliability, supporting Paradromics' broader vision of restoring and enhancing human capabilities for conditions like motor impairment, with plans to expand to neurological disorders such as chronic pain, addiction, and depression in the future.