Elon Musk’s neurotechnology company Neuralink has been ambitious since its founding in 2016. Mission Build next-generation brain implants with at least 100 times Allows for more brain connections than any device currently approved in the US Food and Drug Administration (FDA).
The company has now reached an important milestone. FDA approval start Human experimentation. So what was the problem with keeping this technology in preclinical testing for so long? And have these concerns been addressed?
What is Neuralink?
Neuralink makes Class III medical device known as the brain-computer interface (BCI). This device connects her brain to an external computer via Bluetooth signals, allowing for continuous intercommunication.
The device itself is a coin-sized unit called a link.this is Embedded A precision surgical robot is used to perform surgery within a small disc-shaped notch in the skull. The robot connects a thousand tiny threads from the links to specific neurons in the brain. Each thread is about a quarter the diameter of a human hair.
potential advantage
If Neuralink’s BCI can be made to work safely on humans, I believe so. potential advantage It will be worth the effort.
The company says the device allows for precise control of the prosthetic limb, giving amputees a natural range of motion. It could revolutionize the treatment of Parkinson’s disease, epilepsy, spinal cord injuries and more.It also shows some hope for the potential process obesity, autism, depression, schizophrenia, tinnitus.
Several Other neurotech companies Researchers are already developing BCI technology to help people with limited mobility. regain movement and completion daily tasks.
BCI is also used for: senior citizen Train your motor and cognitive skills to soften the worst effects of aging.
The long road to FDA approval for human trials
of February 2021Musk said Neuralink is working with the FDA to get approval to begin its first human trials later that year. However, human trials did not begin in 2021.
Then, in March 2022, Neuralink will Further application Asked the FDA to confirm whether it is ready to begin human trials.
After one year and three months, on May 25, 2023, Neuralink finally received FDA approval. approval Towards the first human clinical trial. Considering how hard Neuralink has lobbied for permission to launch, we can only assume it will start soon.
This approval came less than six months after the U.S. Inspector General’s approval. started an investigation Reported to Neuralink for possible animal welfare violations.
What was FDA concerned about?
As reported, the FDA had a sizeable list of issues that needed to be resolved before human trials could begin. Reuters surveyclaimed to have spoken to multiple Neuralink sources.
Most of these concerns required Neuralink to perform rigorous, repeated testing and data collection over an extended period of time. Perhaps this was the determining factor in why the approval process to begin human testing took so long.
Not all issues are completely resolved. However, given the rigor of the FDA’s approval process, it might be possible to conclude that the issue has been resolved, at least to the FDA’s satisfaction.
safe surgery
A precision robot known as Implant/r1 will perform the surgery to implant the Neuralink BCI.This robotic surgeon had to undergo severe medical treatment pace To gather evidence that a Neuralink BCI can be reliably and safely implanted and removed without damaging the surrounding brain tissue or causing the risk of infection, bleeding, inflammation or scarring.
harmful side effects
Neuralink BCI should function as intended after porting. It must not unintentionally affect other brain functions or cause undesirable consequences. side effects Seizures, headaches, mood changes, cognitive impairment, etc.
Safe power supply
In particular, overheating of lithium-ion batteries can pose a significant risk to BCI users. Defective such batteries have historically been known to cause problems such as: overheat. An explosion can also occur if the insulation between the cathode and anode (metal electrode components) is broken and a short circuit occurs.
Not only battery life was considered, but also safe and easy replacement from a position under the skin behind the ear. Since its last refusal by the FDA, it has undergone extensive testing. implementation Evaluate performance, durability, and biocompatibility using specially designed Neuralink batteries.
wire transition
Then there is the risk of wire transition. The Link consists of a disc-shaped tip with very thin wire electrodes that connect to neurons in the brain.
Connecting these wires with surgical robots is itself a big challenge. However, it is also possible that the electrodes migrate to different locations in the brain over time due to natural movement, inflammation, or scar tissue formation. This can affect the proper functioning of the device and cause infections and damage to brain tissue.
Neuralink had to conduct large-scale animal studies to provide evidence that the wires didn’t move significantly over time or adversely affect the brain. The company also had to demonstrate that it had a way to track and adjust the wire’s position as needed.
Implant removal
Another challenge Neuralink faced was a secure implant. Removal. The FDA wanted to know how easy or difficult it would be to remove the device from the brain.
Data privacy and security
strong protective measures Necessary to prevent the data collected by the link from being hacked, manipulated or otherwise misused. Neuralink would have needed to not only ensure the privacy of brainwave data generated by the device, but also assure the FDA that hackers could avoid the nightmare scenario of leaving Link users vulnerable to interference. .
road ahead
Critics acknowledge Neuralink’s potential benefits, but the company warns to move slowly. Addressing these issues properly will take time. Don’t cut corners in arriving at a solution.
Beyond potential medical uses for the link, Musk has made many radical claims about his vision for the technology’s future. He said that Neuralink could enhance human intelligence by establishing on-demand connections with artificial intelligence systems, enabling, for example, enhanced memory to improve cognition, learning and problem-solving skills. claim.
He even says the link allows for high bandwidth. telepathy Communication between two or more people connected through an intermediary computer. Common sense would suggest that these claims fall into the “you’ll believe it when you see it” category.
The Neuralink situation clearly parallels current AI advances (and the growing need to regulate AI).
These technologies are interesting, but should not be released to the public until they are proven to be safe. This can only be achieved through thorough testing.
This article is reprinted from conversation Under Creative Commons License.read Original work.