Neuralink pushes forward on implants for speech and vision restoration

Elon Musk’s neurotechnology company Neuralink has received a significant boost with the U.S. Food and Drug Administration (FDA) granting “Breakthrough Device” designation to its brain implant designed to help people with severe speech impairments, reports a Kazinform News Agency correspondent.

photo: QAZINFORM

The FDA’s Breakthrough Device program is intended to accelerate the review of innovative technologies that have the potential to dramatically improve the treatment of life-threatening or severely debilitating conditions. It offers faster regulatory pathways and close collaboration with the agency.

This announcement follows Neuralink’s earlier success in receiving the same designation for its experimental vision-restoring implant, Blindsight. The device is designed to work with the brain’s visual cortex to generate basic images, even for individuals who have lost both eyes and the optic nerve. “Will enable even those who have lost both eyes and their optic nerve to see,” Musk said in a post on X.

Neuralink plans to begin human trials of Blindsight by the end of 2025. The implant will initially offer low-resolution vision comparable to early video game graphics, with the long-term goal of enabling superhuman sight, including infrared and ultraviolet perception. Animal tests have shown stable performance for several years.

At the same time, the company is already testing its “Telepathy” chip in three volunteers with spinal cord injuries or ALS, allowing them to control digital devices with their thoughts. The first human patient to receive a Neuralink implant is reportedly making good progress. “Progress is good, and the patient seems to have lost weight completely, without any negative consequences that we know of,” Musk said. The patient is now learning to control a computer mouse using only their mind.

Neuralink’s recent developments reflect ongoing progress in the company’s efforts to integrate neurotechnology with medical applications aimed at addressing serious neurological conditions.

Earlier, it was reported that Elon Musk’s SpaceX site in southern Texas is set to officially become the city of Starbase. Voters in the area approved the incorporation in a Saturday election, with preliminary results showing 212 votes in favor and 6 against.