US regulator did not allow Neuralink to test neuroimplant in humans

Last year, the US Sanitary Supervision of the Quality of Food and Medicines of the USA (FDA) rejected the Neuralink application and forbade testing a neurochip developed in public. This was reported by the publication reuters with reference to Neuralink.

Neuralink, according to Ilon Mask, will allow “paralyzed to walk, blindly see and will ultimately turn people into cyborgs.” At the presentation of Neuralink on November 30, 2022, Ilon Musk said that in the spring of 2023 the company will receive the approval of FDA for conducting tests in public.

According to informants, the neuro interface has dozens of shortcomings that should be eliminated before the company begins to tests in humans. Moreover, some problems are described as “relatively insignificant.” But there are also serious problems. One of the most important PDA claims is the possibility that tiny electrodes can migrate to other areas of the brain. Such wires can cause inflammation, disrupt the function in the critical areas of the brain and break blood vessels, which can even lead to death.

“potentially serious” fears is caused by a system of charging the device. It is supposed to use lithium batteries that can be charged remotely. Neuralink must confirm FDA that the battery will not fail – otherwise it can damage the brain tissue. Similar fears cause problems with overheating and removing the device.

According to the 12 current and former employees of the company, the problems of Neuralink are largely related to its culture of setting goals and “extremely ambitious terms” to achieve these goals. In addition, in the company Mask at the regulatory authorities look at the obstacle to innovation.

However, most of Neuralink and industry investors believe Ilon Mask. It is believed that it was the Mask’s ambition that contributed to the fact that today Neuralink is estimated at more than $ 1 billion – this is much higher than the cost of competitors, of which about 12 are currently about 12.

Thanks to an implant with electrodes, a 9-year-old Macau named Pager was able to move objects on the monitor using a cursor. The monkey installed the Neuralink implant about 6 weeks before recording a video with a demonstration of the experiment. At first she was taught to play games with a joystick, for which she was awarded with a banana mashed potato, which was served through a special metal tube. While the Pazher played, the Neuralink system collected information about the work of the monkey neurons and learned to transmit information about the movement of the hands.

After studying brain activity, scientists turned off the joystick from the computer. Despite this, in order to get a reward, the monkey continued to play without using a physical controller.

/Media reports cited above.