Brain implant developer Paradromics has secured approval from the US Food and Drug Administration to conduct an early-stage human trial for its device. The Austin-based startup aims to test the high-bandwidth implant to restore speech in individuals with extremely limited movement. The company announced the milestone on Thursday.
Paradromics, an Austin-based startup specializing in brain-computer interfaces, announced on Thursday that it has received approval from the US Food and Drug Administration (FDA) to proceed with an early-stage human trial of its brain implant device.
The high-bandwidth implant is designed to help restore speech capabilities for people suffering from extremely limited movement, such as those with severe paralysis. This breakthrough marks a significant step for the biotech firm in advancing neural technologies that could transform communication for individuals with disabilities.
The trial will focus on testing the device's safety and preliminary efficacy in human subjects, building on prior preclinical work. Paradromics' announcement highlights the growing momentum in brain implant innovations, aligning with broader efforts in science and biotech to bridge the gap between thought and action for those with neurological impairments.