FDA rejects clinical trial application by Earon Mask's brain implant company ``Neuralink'', concerns about implant lithium battery use and removal method
The US Food and Drug Administration (FDA) has rejected the clinical trial application for Neuralink, a company that develops implants to connect to the cranial nerves, which Tesla, SpaceX, and Twitter CEO Elon Musk are working on. It became clear.
US regulators rejected Elon Musk's bid to test brain chips in humans
FDA not OK with Elon Musk's Neuralink tests on humans • The Register
A video of a monkey with a chip embedded in the brain playing a game with only ``thinking'' will be released-GIGAZINE
'Neuralink' aims to embed an implant in the brain that connects human cranial nerves and computers. It is reported that brain activity can be monitored via implants, and that implants can read electrical signals in the brain to ``play games with just thoughts''.
Earon Mask's brain implant company 'Neuralink' hopes to embed a chip in the human brain in the first half of 2023-GIGAZINE
So far, Neuralink has implanted implants in pigs and monkeys, but in December 2022, Mr. Elon Musk expressed his intention to ``implant in humans in the first half of 2023,'' and requested the FDA to submit necessary documents. It was made clear that it was submitting
Clearly that Earon Mask's brain implant company 'Neuralink' is being investigated by the government as repeating illegal animal experiments - GIGAZINE
Seven current and former Neuralink employees told Reuters that Neuralink filed for human clinical trials with the FDA in early 2022, but was rejected with a list of dozens of reasons. It was said that it was done.
Reasons for rejection included concerns over the use of lithium batteries to power the implants, concerns that the wires used in the implants could travel to different parts of the brain, and concerns that the implants would damage brain tissue. It seems that there were concerns about whether it could be removed without it, and concerns about how to remove it.
It is reported that Neuralink is under investigation by the government for repeating illegal animal experiments and improper handling of implants removed from animals that died in experiments.
Approximately two-thirds of clinical trial devices using the human body that require application to the FDA are approved in the first application, and 85% are approved in the second application. For this reason, it seems that Neuralink may also be approved by supplementing the missing parts.
in Hardware, Posted by logc_nt