The US Food and Drug Administration (FDA) has awarded Neuralink’s brain-computer interface breakthrough device designation for the treatment of individuals with severe speech impairment.
The FDA tag is a landmark moment for the Elon Musk-owned brain chip developer, affirming the agency’s positive view of the technology’s use cases for people with quadriplegia.
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Neuralink is now in line for prioritised review for the device’s submission and will also be able to interact quickly with FDA experts to discuss feedback during the premarket review phase.
Neuralink shared limited details but did confirm that the treatment designation includes patients affected by amyotrophic lateral sclerosis, stroke, spinal cord injury, cerebral palsy, multiple sclerosis and other neurological conditions.
Neuralink is currently conducting the PRIME study (NCT06429735) in the US, a human clinical trial evaluating its brain implant and robot device in patients with tetraparesis or tetraplegia.
Brain computer interfaces, also called brain-machine interfaces, are chips implanted in brain tissue that take brain signals and translate them into commands. The measured signals, which can be described as ‘thoughts’, are relayed to a secondary, external device, which then carries out a specific function. Currently, the main application is in the neuromuscular field – helping paralysed patients move muscles.
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By GlobalDataNeuralink is one of several companies developing neural implants, with some at a more advanced clinical stage.
Neuralink’s implant, called N1, is a skull-mounted, wireless, rechargeable implant connected to electrode threads that are implanted in the brain by the R1 Robot, a robotic electrode thread inserter.
The company also has plans for a trial called CONVOY that will run simultaneously with PRIME using cross-enrolling. CONVOY will stud the implant linked with an assistive robotic arm.
Neuralink implanted the first patient with its brain-computer interface in January 2024, after an investigational device exemption was awarded by the US FDA in May 2023.
The first implant has led to viral videos of the patient playing chess on a computer using only his thoughts, along with posting on social media. However, the implant did encounter a few problems, with the device becoming partly detached from the patient’s brain. The implant’s functionality started to decline after some of the threads that connect the chip with the brain began retracting.
A second spinal cord injury patient was implanted in August 2024, with Neuralink saying the participant has been playing video games and started to use 3D design software a month after the surgery.
Musk’s role in spotlight
Elon Musk founded Neuralink in 2016 and played a key role in guiding the company from its early prototypes to its first human trials last year. Recently appointed by US President Donald Trump to head the Department of Government Efficiency (DOGE), Musk has faced increasing scrutiny over his leadership roles at Neuralink and car-maker Tesla.
Tesla’s poor financial performance has led to rumours about the company’s board seeking to replace Musk, reportedly due to his divided attention between the governmental position and his role as company CEO. Tesla’s board denied the allegations.
A major revelation came when Reuters revealed that FDA staff reviewing Neuralink as part of an animal-welfare investigation were part of DOGE employee firings.
Three senators from the Democratic party have this week called for a probe into the collection of neural data from brain-computer interface companies like Neuralink.
