This breakthrough nod extends to a number of neurological conditions, according to a LinkedIn post made by the Elon Musk-backed brain-computer interface (BCI) maker.
“We’ve received Breakthrough Device Designation from the FDA to help restore communication for individuals with severe speech impairment,” Neuralink wrote from its official account. “This includes those affected by ALS, stroke, spinal cord injury, cerebral palsy, multiple sclerosis, and other neurological conditions.”
This breakthrough nod marks the latest milestone for the BCI company. It completed the first human implant of its Telepathy BCI implant in January 2024 and later completed a second implant last year. A nine-minute livestream demonstration showed Noland Arbaugh using the Neuralink BCI to move a computer cursor and play chess online.
Telepathy is being evaluated as a technology that enables people with quadriplegia to control external devices with their thoughts. The remotely rechargeable implant goes along with electrode-laced threads that go further into the brain. The company also has an R1 robot designed to implant the BCI system while avoiding vasculature. It also received approval to launch a U.S. study for its N1 implant controlling a robotic arm.
Learn more about BCIs and some of the players in the space HERE.
