Paradromics Gets FDA Approval to Trial Its Brain Implant in People

Brain implant developer Paradromics has received approval from the US Food and Drug Administration to test its device in an early-stage human trial, the company announced Thursday.

The Austin-based company is aiming to give a digital voice to people who have lost the ability to speak due to severe motor impairment. The trial will assess the long-term safety of the Paradromics device, as well as its ability to enable synthesized speech and text communication.

Paradromics is one of several companies—which include Neuralink, Synchron, Precision Neuroscience, and Cognixion—working on technology to control computers and other devices using brain waves. Known as brain-computer interfaces, or BCIs, these systems capture brain signals associated with movement intention and translate them into commands.

The Paradromics study is slated to begin early next year and include two individuals. After collecting data on the first two participants for a year, the company plans to ask ...