Paradromics Gets FDA Approval to Trial Its Brain Implant in People

Paradromics, an Austin-based brain implant developer, has received FDA approval to begin human trials of its Connexus device, aiming to restore speech for people with severe motor impairments who have lost the ability to speak. The upcoming trial, starting early next year, will initially involve two participants implanted with the device long-term to assess its safety and effectiveness in enabling synthesized speech and text communication. The implant records signals from individual neurons in the brain’s motor cortex, decoding intended speech movements to generate words that can be displayed on a screen and read aloud using AI-generated voice clones, assuming prior voice recordings exist. The Connexus implant is a small metal disk with 421 microwire electrodes that directly interface with brain tissue, allowing for high-bandwidth data transfer between the brain and a computer. Paradromics aims to achieve faster communication speeds, potentially up to 60 words per minute, which is about half the speed of normal speech. This approach contrasts with other brain-computer interfaces (BCIs) like