Neuralink, a company developing brain-computer interface technologies, has received breakthrough device designation from the US Food and Drug Administration (FDA) for its speech restoration implant.
The designation is intended to support the development of devices that may provide more effective treatment for serious conditions when compared to existing alternatives.
The newly designated device is designed to assist individuals who experience severe speech impairments due to a range of neurological conditions.
According to Neuralink, the technology is being developed to restore communication ability in patients affected by amyotrophic lateral sclerosis (ALS), stroke, spinal cord injury, cerebral palsy, multiple sclerosis, and other disorders that disrupt neural communication.
The implant operates by interpreting neural signals associated with speech, with the aim of enabling users to communicate using a computer interface.
The company has stated that it is seeking individuals with relevant medical conditions to participate in future studies through its Patient Registry. Neuralink also indicated that it is recruiting personnel across various teams as development progresses.
This designation follows an earlier breakthrough device status awarded to Neuralink for its “Blindsight” system, which is being developed to address vision loss. That system is intended to stimulate the visual cortex directly, potentially allowing some visual perception in individuals with damaged optic nerves or loss of both eyes.
The breakthrough device programme enables eligible medical technologies to benefit from expedited development and review processes by the FDA. The regulatory pathway aims to bring forward medical solutions that could address unmet clinical needs in a faster and more structured manner.
