erek
[H]F Junkie
- Joined
- Dec 19, 2005
- Messages
- 9,644
"FDA reportedly listed dozens of "deficiencies," including serious safety concerns."
"Another reportedly serious concern from the FDA was that the implant's tiny wires—which are thinner than individual human hairs—could migrate into the brain, potentially causing inflammation, rupturing blood vessels, and impairing brain function. The FDA was also concerned about the device overheating and questioned whether it could be removed from people's brains without causing damage.
While Neuralink may be able to address and overcome all of the FDA's concerns, the company will need to do more animal testing—which current and former employees say Neuralink has handled irresponsibly in the past. Specifically, some have alleged that the company abused research animals, including euthanizing more animals than necessary and performing "hack job" surgeries to meet Musk's rushed deadlines. The Department of Agriculture has opened an investigation into Neuralink over possible animal welfare violations. Similarly, the Department of Transportation is investigating whether Neuralink violated federal transportation regulations when it allegedly shipped brain implants removed from research monkeys infected with a number of dangerous pathogens.
Neuralink did not immediately respond to requests for comment from Ars. Reuters also reported that Neuralink did not respond to requests for comment."
Source: https://arstechnica.com/science/202...man-trials-denied-by-fda-in-2022-report-says/
"Another reportedly serious concern from the FDA was that the implant's tiny wires—which are thinner than individual human hairs—could migrate into the brain, potentially causing inflammation, rupturing blood vessels, and impairing brain function. The FDA was also concerned about the device overheating and questioned whether it could be removed from people's brains without causing damage.
While Neuralink may be able to address and overcome all of the FDA's concerns, the company will need to do more animal testing—which current and former employees say Neuralink has handled irresponsibly in the past. Specifically, some have alleged that the company abused research animals, including euthanizing more animals than necessary and performing "hack job" surgeries to meet Musk's rushed deadlines. The Department of Agriculture has opened an investigation into Neuralink over possible animal welfare violations. Similarly, the Department of Transportation is investigating whether Neuralink violated federal transportation regulations when it allegedly shipped brain implants removed from research monkeys infected with a number of dangerous pathogens.
Neuralink did not immediately respond to requests for comment from Ars. Reuters also reported that Neuralink did not respond to requests for comment."
Source: https://arstechnica.com/science/202...man-trials-denied-by-fda-in-2022-report-says/