The US Food and Drug Administration (FDA) has denied a request from Neuralink, one of Elon Musk's companies, to start experiments aimed at implanting microchips into the human brain.
Founded in 2016, the company is developing technology to implant microchips into the brain to replace damaged parts of the brain, which the company says opens the door to treating currently incurable diseases. such as paralysis, dementia, and blindness.
The company applied to the U.S. Food and Drug Administration for permission to begin human trials, but the agency denied the request due to numerous concerns about the company's equipment, Reuters reports, based on interviews with seven current and former Neuralink employees.
According to the report, the US Food and Drug Administration has raised alarming concerns about the safety of battery-powered devices. She explained that the company must conduct animal tests to prove that the battery is less likely to fail and does not damage brain tissue. The agency has also raised serious concerns about the tiny wires the company uses in its devices, which can increase the risk of encephalitis, dysfunction, and ruptured blood vessels. The agency also expressed concern about the device's high temperature and asked if it could be removed from people's brains without causing harm.
The refusal put the company's ambitious plans in limbo. Musk has previously said that Neuralink aims to begin human trials by the end of 2020, but according to Reuters, in a speech in November 2022, Musk said the company is about six months away from starting human trials.
Despite these hurdles, Neuralink hopes to perfect its technology in the near future, but it needs to address the FDA's concerns and conduct more animal testing before moving to human trials.
The report also highlighted allegations of animal cruelty made by some former employees of Neuralink. Some have claimed that the company killed too many animals and rushed through operations to meet Musk's deadlines.
Neuralink's research is based on a technology known as a brain-computer interface, which aims to enable people to communicate directly with computers and other devices through their brains. This technique works by inserting tiny wire-like electrodes into the brain through a small incision. These electrodes record the electrical signals that the brain uses to communicate with the rest of the body.
Neuralink devices use advanced algorithms and machine learning techniques to interpret these signals, which can be used to control other devices or repair brain damage.
Neuralink's long-term goal is to create a secure, easy-to-use, high-bandwidth brain-computer interface accessible to everyone. The company is also exploring the potential of its technology to treat various neurological diseases such as Alzheimer's and Parkinson's. However, the technology must pass rigorous testing and be approved by specialized regulatory agencies such as the US Food and Drug Administration (FDA) before it can be used on humans.