埃隆·馬斯克的腦機接口公司Neuralink開啟人體臨床試驗

埃隆·馬斯克的腦機接口公司Neuralink周四表示，該公司已獲得美國食品藥品監督管理局（FDA）的準許，啟動其首次人體臨床研究，這是在早些時候難以獲得準許後的一個關鍵裡程碑。

自2019年以來，馬斯克至少四次預測，他的醫療裝置公司将開始大腦植入物的人體試驗，以治療癱瘓和失明等嚴重疾病。

然而，該公司成立于2016年，直到2022年初才尋求美國食品藥品監督管理局的準許，七名現任和前任員工在3月份告訴路透社，該管理機構拒絕了申請。

據馬斯克的員工稱，美國食品藥品監督管理局向Neuralink指出了在準許人體試驗之前需要解決的幾個問題。主要問題涉及該裝置的锂電池、植入物導線在大腦内遷移的可能性，以及在不損傷腦組織的情況下安全取出該裝置的挑戰。

美國食品藥品監督管理局星期四準許這一決定之際，美國立法者正在敦促監管機構調查Neuralink動物試驗監督小組的組成是否導緻了糟糕、倉促的實驗。

Neuralink已經成為美國聯邦調查的對象。

路透社2022年12月5日的報道稱，應聯邦檢察官的要求，美國農業部監察長正在調查可能違反《動物福利法》的行為，該法規定了研究人員如何對待和測試某些類型的動物。

調查還關注了美國農業部對Neuralink的監督。

Neuralink在周四的一條推文中表示，它尚未開放臨床試驗。

Neuralink在周四的推文中表示：“這是Neuralink團隊與美國食品藥品監督管理局密切合作所取得的令人難以置信的成果，也是重要的第一步，有一天我們的技術将幫助許多人”。

May 25 (Reuters) - Elon Musk's brain-implant company Neuralink on Thursday said it had received a green light from the U.S. Food and Drug Administration (FDA) to kickstart its first-in-human clinical study, a critical milestone after earlier struggles to gain approval.

On at least four occasions since 2019, Musk has predicted that his medical device company would begin human trials for a brain implant to treat severe conditions such as paralysis and blindness.

Yet the company, founded in 2016, only sought FDA approval in early 2022 - and the agency rejected the application, seven current and former employees told Reuters in March.

The FDA had pointed out several concerns to Neuralink that needed to be addressed before sanctioning human trials, according to the employees

Major issues involved the lithium battery of the device, the possibility of the implant's wires migrating within the brain, and the challenge of safely extracting the device without damaging brain tissue.

Thursday's FDA approval comes as U.S. lawmakers are urging regulators to investigate whether the make-up of a panel overseeing animal testing at Neuralink contributed to botched and rushed experiments.

Neuralink has already been the subject of federal probes.

Reuters reported on Dec. 5 that the USDA's Inspector General was investigating, at the request of a federal prosecutor, potential violations of the Animal Welfare Act, which governs how researchers treat and test certain types of animals.

The probe has also been looking at the USDA's oversight of Neuralink.

In a tweet on Thursday, Neuralink said it is not yet open for a clinical trial.

"This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our technology to help many people," Neuralink said in a tweet on Thursday.