Concerns over Neuralink Chip

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Elon Musk's company Neuralink gets the U.S. Food and Drug Administration's (FDA) approval for study of brain implants in humans.

Neuralink is brain-implant Company, co-founded by Elon Musk.
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 cut-out 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.

If the Neuralink successfully works in humans, it would have wide range of benefits.
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 can also be used in the treatment of obesity, autism, depression, schizophrenia and tinnitus.

Neuralink finally received FDA approval for its first human clinical trial in May 2023.
The FDA had also raised a list of concerns that needed to be resolved before human trials could commence.
Safe surgery - A precision robot known as Implant/r1 performs the surgical procedure to implant the Neuralink BCI.
This robot should be reliably and safely implant and remove the Neuralink BCI without damaging surrounding brain tissue.
Harmful side effects - The implanted Neuralink BCI must not unintentionally influence other brain functions.
It should not cause any unwanted side effects such as seizures, headaches, mood changes, or cognitive impairment.
Safe power supply - Overheating lithium-ion batteries can pose great risk to BCI users.
Wire migration - The Link consists of a disk-shaped chip with very thin wire electrodes that connect to neurons in the brain.
There is the risk of wire migration over time due to natural movement, inflammation, or scar tissue formation.
Implant removal - The safety and difficulty of removal of implants.
Data privacy and security - Safeguards of the data collected against being hacked, manipulated or otherwise misused.

Extensive animal studies have been conducted by Neuralink.
It provides evidence that its wires did not migrate significantly over time, or cause any adverse effects on the brain.
The company also has come up with a method for tracking and adjusting the position of the wires to overcome wire migration.
Neuralink specially designed battery to evaluate its performance, durability and bio-compatibility.

Musk has made many radical claims regarding his future vision for the technology beyond its potential medical use.
He claims Neuralink could augment human intelligence by creating an on-demand connection with artificial intelligence systems.
For example, improved cognition through enhanced memory, and improved learning and problem-solving skills.
Neuralink with at this growth pace needs regulation.
The cutting edge technology must not be released to the public until proven to be safe and this requires exhaustive testing.

Class III medical device

The Food and Drug Administration (FDA) has established classifications for different generic types of devices.
Each of these generic types of devices is assigned to one of three regulatory classes - Class I, Class II and Class III.
- Class I General Controls
- Class II General Controls and Special Controls
- Class III General Controls and Premarket Approval
It is assigned based on the level of control necessary to assure the safety and effectiveness of the device.
Class III includes those with the greatest risk like pacemakers and breast implants.
These devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury.
For Class III devices, a premarket approval application (PMA) is required.