Shulou(Shulou.com)11/24 Report--

Beijing, March 2 (Beijing)-Elon Musk has predicted on at least four occasions since 2019 that his brain-computer interface company Neuralink will soon launch a revolutionary human trial of brain implants to treat difficult diseases such as paralysis and blindness. However, Neuralink's application for human trials has been rejected because of safety concerns.

Neuralink's application for human trials was rejected according to seven current and former Neuralink employees. The company, which was founded in 2016, did not seek permission from the US Food and Drug Administration (FDA) for human trials until early 2022, but was rejected. The rejection of the Neuralink application has not been reported before.

In explaining the refusal to Neuralink, FDA outlined dozens of issues that the company must address before conducting human trials, the employees said. Human trials are a key milestone on the road to final product approval. FDA's main safety concerns relate to the device's lithium battery; the possibility that tiny wires from the implant could be transferred to other parts of the brain; and whether and how to remove the device without damaging brain tissue.

A year after being rejected by FDA, Neuralink is still trying to address the agency's concerns. Three employees said they doubted Neuralink would be able to solve these problems quickly, although Mr Musk predicted at a demonstration on November 30 last year that the company would receive approval for human trials by FDA this spring.

Neuralink has not disclosed the details of its application for human trials, FDA's rejection or the extent of the agency's concerns. As a private company, it does not need to disclose such regulatory interactions to investors. In a multi-hour demonstration last November, Mr Musk said the company had submitted "most of the documents" to FDA, but did not specify any formal applications. Neuralink executives acknowledge that FDA raised security issues in what they called ongoing conversations.

People familiar with the matter from Neuralink declined to provide FDA's written refusal document, which is a confidential document protected by law. Neuralink's anonymous staff described security issues in an interview, including four people who had read the FDA documents and others who were aware of the agency's concerns.

FDA's refusal does not mean that Neuralink will eventually be unable to obtain the agency's approval for human trials. But the agency's refusal is a sign of the seriousness of concerns, according to more than a dozen experts in the FDA device approval process. The rejection also increases the risk and difficulty of the company's subsequent application for trial approval, experts say. FDA says it has approved about 2/3 of applications for first-time human trials of devices in the past three years. After the second review, the proportion rose to 85 per cent. But some experts say companies often give up after three attempts to address FDA concerns, rather than investing more time and money on expensive research. Companies that are approved for human trials usually conduct at least two rounds of trials before applying for FDA approval for commercial equipment.

Mr Musk and other Neuralink executives have not commented on the company's equipment or its application to FDA for human trials. FDA declined to comment on Neuralink, citing laws that protect private business information.

Welcome to subscribe "Shulou Technology Information " to get latest news, interesting things and hot topics in the IT industry, and controls the hottest and latest Internet news, technology news and IT industry trends.