Elon Musk’s brain-implantation startup Neuralink have now received the letter of approval with the U.S. Food and Drug Administration. After the approval Neuralink, can initiate with company’s first human clinical study.
The company, Neuralink is working on a device that will grant permission to the users to control computer interfaces by using their brains. Neuralink said that the devices would help in restoring the vision and enable people with severe disabilities to move and communicate by decoding brain activity.
Neuralink is planning to open clinics where surgical robots will implant these devices into the brains of humans. The robot surgeon threads Neuralink’s proprietary electrodes, or brain-signal recording wires into the brain.
In an official tweet, Neuralink said that the entire team of Neuralink is feeling excited to share that they have received the FDA’s approval to launch the first-in-human clinical study.
The company said that the company hasn’t opened recruitment for its trial.
Musk in 2019 said that the company planned to apply for FDA approval for human testing. At the time he predicted that the approval regarding the same would be in place in 2020.
Neuralink made a release of a video in April 2021, that highlights that a monkey implanted with two Neuralink devices and could play a videogame called Pong by the help of the brain.
During a demonstration, Musk reflected a video of “telepathic typing” from a monkey with a Neuralink brain implant. In that particular video, the animal used his brain to move a cursor to images of letters during the demonstration.
Neuralink device is safe and effective for the long-term as per the clinic testing. Neuralink has euthanized several of its monkeys for suspected device-associated infections.
Also as per the state of the company, the device is associated with some of the infections that are an inherent risk with any medical device that implants through the skin. The company later developed new surgical protocol for the same.
