FDA Rejects Neuralink's Bid to Start Human Trials Over "Dozens" of Safety Issues
Neuralink's brain implants aren't quite ready for humans yet – at least that's what the Food and Drug Administration (FDA) thinks.
According to Reuters, the Elon Musk-owned brain-computer interface (BCI) startup's request to start human trials for its brain implants was rejected by the FDA over "dozens" of safety concerns.
"The agency’s major safety concerns involved the device’s lithium battery; the potential for the implant’s tiny wires to migrate to other areas of the brain; and questions over whether and how the device can be removed without damaging brain tissue," Neuralink employees told Reuters.
One of the concerns centres around the likelihood of the battery system rupturing inside the test subject's brain. The agency reportedly wants reassurances that the battery "is very unlikely to fail" during trials because if it does, the discharge of electrical current or heat from it could damage brain tissue.
Another concern is that, in the event the implant needs to be removed, be it for replacement or upgrades, there's a risk of it breaking off and getting lodged somewhere it could cause damage or adverse effects. The implant is said to be small and delicate, so even regular use makes this a possible scenario.
Late last year, Neuralink faced a federal probe over alleged animal welfare violations in its research testing. The probe, launched by the U.S. Department of Agriculture's (USDA) Inspector General, came amid complaints from employees that the startup was rushing testing, causing needless suffering and deaths to animals. Internal documents reviewed by Reuters found that the startup's testing has killed 1,500 animals since 2018, including more than 280 sheep, pigs and monkeys.
Elon Musk said in November 2022 that Neuralink would be able to secure FDA approval "within six months" after allegations surfaced that he was pressuring employees to work faster.
"He can’t appreciate that this is not a car," one employee for the startup told Reuters. "This is a person’s brain. This is not a toy."
Neuralink's request to start human trials for its brain implants was rejected by the FDA over "dozens" of safety concerns.
The agency reportedly wants reassurances that the battery "is very unlikely to fail" during trials because if it does, the discharge of electrical current or heat from a ruptured pack could damage brain tissue.
Another concern is that, in the event the implant needs to be removed, be it for replacement or upgrades, there's a risk of it breaking off and getting lodged somewhere it could cause damage or adverse effects.
Elon Musk said in November 2022 that Neuralink would be able to secure FDA approval "within six months" after allegations surfaced that he was pressuring employees to work faster.
