What is Neuralink?
Neuralink Corporation is an American neurotechnology company.
Founders: Elon Musk, Max Hodak
Founded in 2016.
Since its founding Neuralink has had the ambitious mission to build a next-generation brain implant with at least 100-times more brain connections than devices currently approved by the U.S. Food and Drug Administration (FDA).
Neuralink is making a Class III medical device known as a brain-computer interface (BCI).
The device connects the brain to an external computer via a Bluetooth signal, enabling continuous communication back and forth.
The device itself is a coin-sized unit called a Link.
It’s implanted within a small disk-shaped cutout in the skull using a precision surgical robot.
The robot splices a thousand tiny threads from the Link to certain neurons in the brain.
Each thread is about a quarter the diameter of a human hair.
Potential benefits of BCI
The company says the device could enable precise control of prosthetic limbs, giving amputees natural motor skills.
It could revolutionise treatment for conditions such as Parkinson’s disease, epilepsy and spinal cord injuries.
It also shows some promise for potential treatment of obesity, autism, depression, schizophrenia and tinnitus.
BCIs have also been used to help older people train their motor and cognitive abilities to moderate the worst effects of ageing.
Several other neurotechnology companies and researchers have already developed BCI technologies that have helped people with limited mobility regain movement and complete daily tasks.
FDA’s concerns
Safe surgery - A precision robot known as Implant/r1 performs the surgical procedure to implant the Neuralink BCI.
It must ensure no damaging surrounding brain tissue, or creating the risk of infection, bleeding, inflammation or scarring.
Repeated testing and data collection over an extended period.
Harmful side effects - It must not unintentionally influence other brain functions, or cause any unwanted side effects such as seizures, headaches, mood changes, or cognitive impairment.
Safe power supply — In particular, overheating lithium-ion batteries can pose great risk to BCI users. They can even explode if the insulation breaks down, resulting in a short circuit.
The longevity of the battery.
Wire migration — Then there is the risk of wire migration.
Connecting these wires by means of a surgical robot is a major challenge in itself.
There is also the possibility the electrodes could move elsewhere in the brain over time due to natural movement, inflammation, or scar tissue formation.
Could cause infection or damage to the brain tissue.
Implant removal - need for safe implant removal.
Data privacy and security — Strong safeguards are required to prevent data collected by the Link from being hacked, manipulated or otherwise misused.
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