Elon Musk's brain-implant company Neuralink on Thursday said the U.S. Food and Drug Administration (FDA) had given the green light to its first-in-human clinical trial, a critical milestone after earlier struggles to gain approval.
The FDA nod "represents an important first step that will one day allow our technology to help many people," Neuralink said in a tweet. It did not elaborate on the aims of the study, saying only that it was not recruiting yet and more details would be available soon.
Neuralink and the FDA did not immediately respond to Reuters requests for comment.
Musk envisions brain implants could cure a range of conditions including obesity, autism, depression and schizophrenia as well as enabling web browsing and telepathy. He made headlines late last year when he said he was so confident in the devices' safety that he would be willing to implant them in his children.
On at least four occasions since 2019, Musk predicted Neuralink would begin human trials. But the company 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.
Neuralink, founded in 2016, has been the subject of several federal probes.
In May, U.S. lawmakers urged regulators to investigate whether the makeup of a panel overseeing animal testing at Neuralink contributed to botched and rushed experiments.
The Department of Transportation is separately probing whether Neuralink illegally transported dangerous pathogens on chips removed from monkey brains without proper containment measures.
Neuralink is also under investigation by the U.S. Department of Agriculture's Office of Inspector General for potential animal-welfare violations. This probe has also been looking at the USDA's oversight of Neuralink.
Neuralink has not responded to requests for comment on the probes.
Reuters
Fri May 26 2023
Musk envisions brain implants could cure a range of conditions including obesity, autism, depression and schizophrenia as well as enabling web browsing and telepathy. - REUTERS/Filepic
Lawatan negara Anwar ke Pakistan raih potensi perdagangan RM2.65 bilion - Tengku Zafrul
Pakistan turut beri komitmen untuk tingkat import minyak kelapa sawit dari Malaysia dan import produk berasaskan kayu, baja, petrokimia.
Tiada potensi penyelesaian diplomatik konflik Israel-Palestin
PM Anwar Ibrahim akui usaha diplomatik gagal hentikan kekejaman Israel di Palestin dan Lubnan, menyalahkan sokongan kuat dari Amerika Syarikat sebagai punca.
Malaysia dan Pakistan perkukuh kerjasama menentang ekstremisme
PM Anwar Ibrahim menyeru Malaysia dan Pakistan untuk memperhebat usaha bersama dalam memerangi keganasan melalui kerjasama risikan, strategi, dan pembaharuan pendidikan serta sosial.
Malaysia-Pakistan sasar tingkatkan hubungan perdagangan
PM Anwar Ibrahim dan Shehbaz Sharif komited meningkatkan perdagangan antara Malaysia dan Pakistan, dengan fokus pada eksport, teknologi pertanian, farmaseutikal, dan kerjasama sektor pekerja mahir.
Anwar akui usaha diplomatik hentikan kedegilan, kekejaman Israel tidak berkesan
Keberanian Israel bertindak sesuka hati di Palestin dan Lubnan, mungkin disebabkan sokongan diterima daripada Amerika Syarikat, tegas Perdana Menteri.
[LAPOR LANGSUNG] Israel terus mengganas, 37 maut di Lubnan dalam tempoh 24 jam lalu
Sekurang-kurangnya 37 orang terbunuh sementara 151 lagi cedera akibat serangan Israel di seluruh Lubnan pada Khamis.
Israel terus mengganas, 37 maut di Lubnan dalam tempoh 24 jam lalu
Letupan besar kedengaran di Beirut dengan imej dari ibu negara Lubnan itu menunjukkan langit malam menyala di kawasan selatan bandar itu.
Pangkalan tentera utama Israel binasa, lebih 20 jet pejuang musnah
Imej satelit menunjukkan kesan kemusnahan hangar pesawat di pangkalan utama tentera udara Israel selepas ia dibedil Iran di bawah Operasi Janji Benar 2.0.
Israel tekad terus serang Hezbollah di Beirut - Ketua tentera
Tentera Israel "tekad untuk memusnahkan" infrastruktur Hezbollah berhampiran sempadan Lubnan dan akan terus melakukan kerosakan terhadap kumpulan itu.
Deklarasi Doha seru gencatan senjata dan bantuan kemanusiaan untuk Gaza
Deklarasi Doha dengan tumpuan pada "Diplomasi Sukan," menekankan keperluan mendesak untuk gencatan senjata segera dan menyeluruh di Gaza.
Manusia pertama dengan implan Neuralink kini boleh kawal tetikus melalui fikiran - Elon Musk
Pengguna tersebut dilapor berjaya mengawal tetikus dan menggerakkannya pada skrin hanya dengan berfikir.
Implan otak Neuralink telah dipasang pada manusia - Boleh mengawal peranti dan komputer
Neuralink syarikat tunas rintis milik Elon Musk telah memasang implan otak pertama mereka pada manusia pertama semalam.
Tujuh petua produktiviti daripada Elon Musk
Tiada yang mustahil untuk mencapai sesuatu impian 'gila', cuma perlu disusun atur kerjanya supaya efisyen dan produktif. Ini petua dari CEO Tesla, Elon Musk.