Neuralink was reportedly denied FDA authorization to start human trials

During Neuralink's first full unveiling presentation in 2019, founder Elon Musk claimed the company would one day insert computer chips into people's brains to fight diseases and mitigate the existential threat of AI.

It would always be a long-term development process, but Musk said at the time the company hoped to test its chip in humans before the end of 2020.

Almost four years later, the FDA has reportedly denied Neuralink authorization to conduct human trials using its brain-computer interface (BCI) devices. The main reason is that it has killed numerous animals during trials, as per a Reuters report.

Neuralink denied authorization to go to human trials

Neuralink was reportedly denied FDA authorization to conduct human trials in 2022 in the same year that reports emerged the company had violated animal welfare and allegedly killed thousands of animals.

"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," current and former Neuralink employees told Reuters.

According to the Reuters report, the FDA is seeking reassurances about the BCI company's battery system, which uses novel transdermal charging capabilities. This is because a battery failure could cause a surge of electrical current or heat that could lead to severe irreparable brain damage.

The FDA is also concerned with the damage the device could cause during a removal procedure. This is mainly due to the tiny electrical leads inserted into a patient's (or user's) grey matter. Those electrical leads are so small that the FDA fears they could break during removal, migrate to other brain parts, and cause damage.

Neuralink employees reportedly call out Elon Musk's behavior

Musk's predictions about when Neuralink will test its hardware on humans are aging about, as well as his estimations for when the Tesla Cybertruck might finally enter production.

Critics have also compared Musk's statement that Neuralink's product was ready for human trials to his false claim that Tesla was close to achieving Level 5 autonomy — a leaked memo from Tesla employees called this claim an exaggeration.

In this light, the latest report comes across as a savage indictment of Musk's penchant for overemphasizing his company's achievements, even when lives might be on the line: "He can't appreciate that this is not a car," one Neuralink employee reportedly told Reuters. "This is a person's brain. This is not a toy."

Source: Reuters