{"id":538343,"date":"2023-05-25T22:56:58","date_gmt":"2023-05-26T04:56:58","guid":{"rendered":"https:\/\/cerebrodigital.net\/neuralink-finalmente-obtiene-la-aprobacion-de-la-fda-para-pruebas-en-humanos-eacr\/"},"modified":"2023-05-25T23:02:42","modified_gmt":"2023-05-26T05:02:42","slug":"neuralink-finally-gets-fda-approval-for-human-testing-eacr","status":"publish","type":"post","link":"https:\/\/cerebrodigital.net\/en\/neuralink-finally-gets-fda-approval-for-human-testing-eacr\/","title":{"rendered":"Neuralink Finally Gets FDA Approval For Human Testing"},"content":{"rendered":"\n<p>As 2022 came to an end, Elon Musk said that Neuralink was on track to begin human trials involving its brain-chip interface tech within the next few months. Today, the <a href=\"https:\/\/www.slashgear.com\/1297236\/elon-musk-neuralink-gets-fda-approval-human-testing\/\" target=\"_blank\" rel=\"noopener\">company announced that it has received approval<\/a> from the U.S. Food and Drug Administration (FDA) to launch its first\u00a0clinical trial involving human subjects. However, the company hasn&#8217;t started the recruitment process yet.<\/p>\n\n\n\n<figure class=\"wp-block-image aligncenter size-large is-resized\"><img fetchpriority=\"high\" decoding=\"async\" src=\"https:\/\/cerebrodigital.net\/wp-content\/uploads\/2023\/05\/neuralink_kjhbd-mitchell-1024x576.jpg\" alt=\"-\" class=\"wp-image-538333\" width=\"512\" height=\"288\" title=\"\" srcset=\"https:\/\/cerebrodigital.net\/wp-content\/uploads\/2023\/05\/neuralink_kjhbd-mitchell-1024x576.jpg 1024w, https:\/\/cerebrodigital.net\/wp-content\/uploads\/2023\/05\/neuralink_kjhbd-mitchell-300x169.jpg 300w, https:\/\/cerebrodigital.net\/wp-content\/uploads\/2023\/05\/neuralink_kjhbd-mitchell-768x432.jpg 768w, https:\/\/cerebrodigital.net\/wp-content\/uploads\/2023\/05\/neuralink_kjhbd-mitchell-696x392.jpg 696w, https:\/\/cerebrodigital.net\/wp-content\/uploads\/2023\/05\/neuralink_kjhbd-mitchell-1068x601.jpg 1068w, https:\/\/cerebrodigital.net\/wp-content\/uploads\/2023\/05\/neuralink_kjhbd-mitchell-747x420.jpg 747w, https:\/\/cerebrodigital.net\/wp-content\/uploads\/2023\/05\/neuralink_kjhbd-mitchell-150x84.jpg 150w, https:\/\/cerebrodigital.net\/wp-content\/uploads\/2023\/05\/neuralink_kjhbd-mitchell.jpg 1200w\" sizes=\"(max-width: 512px) 100vw, 512px\" \/><\/figure>\n\n\n\n<p>The FDA approval follows a December 2022 announcement from Neuralink regarding the start of its patient registration process for volunteers willing to participate in human trials. Back then, the Musk-backed company was only inviting people living with conditions such as quadriplegia, vision loss, and the inability to speak, all of which it aims to cure with its brain implant.<\/p>\n\n\n\n<figure class=\"wp-block-embed is-type-rich is-provider-twitter wp-block-embed-twitter\"><div class=\"wp-block-embed__wrapper\">\n<div class=\"embed-twitter\"><blockquote class=\"twitter-tweet\" data-width=\"500\" data-dnt=\"true\"><p lang=\"en\" dir=\"ltr\">We are excited to share that we have received the FDA\u2019s approval to launch our first-in-human clinical study!<br><br>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\u2026<\/p>&mdash; Neuralink (@neuralink) <a href=\"https:\/\/twitter.com\/neuralink\/status\/1661857379460468736?ref_src=twsrc%5Etfw\" target=\"_blank\" rel=\"noopener\">May 25, 2023<\/a><\/blockquote><script async src=\"https:\/\/platform.twitter.com\/widgets.js\" charset=\"utf-8\"><\/script><\/div>\n<\/div><\/figure>\n\n\n\n<p>While skepticism remains about the promises made by Neuralink, the company has been actively looking for clinical partners to test its invasive brain-interface chip for a while now. The FDA approval is a major victory for Neuralink, as its last attempt to get such approval was unsuccessful. According to a March 2023 report by\u00a0Reuters, insiders claimed the clinical trial application was rejected due to potential safety risks posed by the wires, alleged concerns over safe removal, and the lithium battery pack powering the device.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Rough journey so far, but tougher roads are ahead<\/h2>\n\n\n\n<figure class=\"wp-block-image aligncenter size-full is-resized\"><img decoding=\"async\" src=\"https:\/\/cerebrodigital.net\/wp-content\/uploads\/2023\/05\/chip-neuralink-jkhb.jpg\" alt=\"-\" class=\"wp-image-538337\" width=\"581\" height=\"323\" title=\"\" srcset=\"https:\/\/cerebrodigital.net\/wp-content\/uploads\/2023\/05\/chip-neuralink-jkhb.jpg 774w, https:\/\/cerebrodigital.net\/wp-content\/uploads\/2023\/05\/chip-neuralink-jkhb-300x167.jpg 300w, https:\/\/cerebrodigital.net\/wp-content\/uploads\/2023\/05\/chip-neuralink-jkhb-768x427.jpg 768w, https:\/\/cerebrodigital.net\/wp-content\/uploads\/2023\/05\/chip-neuralink-jkhb-696x387.jpg 696w, https:\/\/cerebrodigital.net\/wp-content\/uploads\/2023\/05\/chip-neuralink-jkhb-756x420.jpg 756w, https:\/\/cerebrodigital.net\/wp-content\/uploads\/2023\/05\/chip-neuralink-jkhb-150x83.jpg 150w\" sizes=\"(max-width: 581px) 100vw, 581px\" \/><\/figure>\n\n\n\n<p>Neuralink, which is currently testing its brain interface tech on monkeys (and which has also been accused of animal cruelty), targets the brain&#8217;s motor cortex and claims to have the potential to fix everything from complete blindness at birth to restoring full-body movement in cases of paralysis. In a presentation that he gave last year about the tech&#8217;s progress, Musk demonstrated two monkeys controlling a computer cursor with their minds via signals transmitted by the Neuralink implant. Another public demonstration showcased a macaque playing ping pong in a similar fashion.<\/p>\n\n\n\n<p>In March, Reuters claimed the company had approached Arizona-based Barrow Neurological Institute about partnering with it for eventual human clinical trials, but so far, an official announcement about any such arrangement is yet to come. Meanwhile, it was reported in December 2022 that Neuralink faced an investigation by the U.S. Department of Agriculture over alleged animal welfare code violations. A couple of months later, the U.S. Department of Transportation kicked off a probe into the company over its alleged mishandling of hazardous materials as part of its animal trials.<\/p>\n\n\n\n<p>Musk has said\u00a0that the goal is to make the Neuralink brain chip implant process as simple as getting a LASIK eye surgery. Speaking on an episode of MIT researcher Lex Fridman&#8217;s podcast, Musk claimed\u00a0controversially that Neuralink<em> &#8220;solves a lot of brain-related diseases. Could be anything from autism, schizophrenia, and memory loss.&#8221;<\/em> In the past, Musk also suggested that Neuralink could help treat\u00a0disorders like Parkinson&#8217;s and Alzheimer&#8217;s disease.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>As 2022 came to an end, Elon Musk said that Neuralink was on track to begin human trials involving its [&hellip;]<\/p>\n","protected":false},"author":32,"featured_media":538334,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"two_page_speed":[],"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_post_was_ever_published":false},"categories":[107202,107131],"tags":[109255,108888,109256,109252],"class_list":["post-538343","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-neurosciences","category-technology","tag-brain-chip","tag-fda-en","tag-human-tests","tag-neuralink-en"],"jetpack_featured_media_url":"https:\/\/cerebrodigital.net\/wp-content\/uploads\/2023\/05\/neuralink_kjhbd-mitchell.jpg","jetpack_sharing_enabled":true,"jetpack_likes_enabled":false,"jetpack_shortlink":"https:\/\/wp.me\/pdR79Q-2g2X","jetpack-related-posts":[{"id":544699,"url":"https:\/\/cerebrodigital.net\/en\/neuralink-obtains-permission-to-implant-brain-chips-in-humans-eacr\/","url_meta":{"origin":538343,"position":0},"title":"Neuralink obtains permission to implant brain chips in humans","author":"Andrey Robles","date":"September 19, 2023","format":false,"excerpt":"Neuralink, the brain-chip startup founded by Elon Musk, has received approval to initiate its first human trial focusing on patients with paralysis caused by cervical spinal cord injuries or amyotrophic lateral sclerosis (ALS). The trial was initially planned for 10 participants, but negotiations with the U.S. Food and Drug Administration\u2026","rel":"","context":"In &quot;Ciencia&quot;","block_context":{"text":"Ciencia","link":"https:\/\/cerebrodigital.net\/en\/category\/news-en\/ciencia-noticias-en\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/cerebrodigital.net\/wp-content\/uploads\/2023\/09\/Neuralink_jkhg-bell.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/cerebrodigital.net\/wp-content\/uploads\/2023\/09\/Neuralink_jkhg-bell.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/cerebrodigital.net\/wp-content\/uploads\/2023\/09\/Neuralink_jkhg-bell.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/cerebrodigital.net\/wp-content\/uploads\/2023\/09\/Neuralink_jkhg-bell.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/cerebrodigital.net\/wp-content\/uploads\/2023\/09\/Neuralink_jkhg-bell.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":544760,"url":"https:\/\/cerebrodigital.net\/en\/the-gruesome-story-of-how-neuralinks-monkeys-really-died-eacr\/","url_meta":{"origin":538343,"position":1},"title":"The gruesome story of how Neuralink&#8217;s monkeys really died","author":"Andrey Robles","date":"September 20, 2023","format":false,"excerpt":"Elon Musk and his biotech startup, Neuralink, face fresh allegations of potential securities fraud related to statements Musk made concerning the deaths of primates used for research at the company. An ethics group, the Physicians Committee for Responsible Medicine, has called on the US Securities and Exchange Commission (SEC) to\u2026","rel":"","context":"In &quot;Tecnolog\u00eda&quot;","block_context":{"text":"Tecnolog\u00eda","link":"https:\/\/cerebrodigital.net\/category\/noticias\/noticias-tecnologia\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/cerebrodigital.net\/wp-content\/uploads\/2023\/09\/musk_neuralink_monos_jhd-bspline.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/cerebrodigital.net\/wp-content\/uploads\/2023\/09\/musk_neuralink_monos_jhd-bspline.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/cerebrodigital.net\/wp-content\/uploads\/2023\/09\/musk_neuralink_monos_jhd-bspline.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/cerebrodigital.net\/wp-content\/uploads\/2023\/09\/musk_neuralink_monos_jhd-bspline.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/cerebrodigital.net\/wp-content\/uploads\/2023\/09\/musk_neuralink_monos_jhd-bspline.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":538432,"url":"https:\/\/cerebrodigital.net\/esta-semana-en-la-ciencia-del-22-al-28-de-mayo-del-2023\/","url_meta":{"origin":538343,"position":2},"title":"Esta semana en la ciencia del 22 al 28 de mayo del 2023","author":"Alejandra Galaz","date":"May 28, 2023","format":false,"excerpt":"Neuralink finalmente obtiene la aprobaci\u00f3n de la FDA para pruebas en humanos Cuando 2022 lleg\u00f3 a su fin, Elon Musk dijo que Neuralink estaba en camino de comenzar las pruebas en humanos con su tecnolog\u00eda de interfaz de chip cerebral en los pr\u00f3ximos meses. 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The company demonstrated how this neural network interacts with the video game Doom, processing stimuli and generating actions in real time. It is a public demo, not yet a formally peer-reviewed study.\u2026","rel":"","context":"In \"noticias\"","block_context":{"text":"noticias","link":"https:\/\/cerebrodigital.net\/en\/tag\/noticias-en\/"},"img":{"alt_text":"Investigadores ense\u00f1an a una \u201ccomputadora biol\u00f3gica\u201d llamada CL1 que est\u00e1 hecha con c\u00e9lulas cerebrales humanas a jugar Doom","src":"https:\/\/i0.wp.com\/cerebrodigital.net\/wp-content\/uploads\/2026\/03\/image-5.png?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/cerebrodigital.net\/wp-content\/uploads\/2026\/03\/image-5.png?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/cerebrodigital.net\/wp-content\/uploads\/2026\/03\/image-5.png?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/cerebrodigital.net\/wp-content\/uploads\/2026\/03\/image-5.png?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/cerebrodigital.net\/wp-content\/uploads\/2026\/03\/image-5.png?resize=1050%2C600&ssl=1 3x"},"classes":[]}],"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/cerebrodigital.net\/en\/wp-json\/wp\/v2\/posts\/538343","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/cerebrodigital.net\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cerebrodigital.net\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cerebrodigital.net\/en\/wp-json\/wp\/v2\/users\/32"}],"replies":[{"embeddable":true,"href":"https:\/\/cerebrodigital.net\/en\/wp-json\/wp\/v2\/comments?post=538343"}],"version-history":[{"count":3,"href":"https:\/\/cerebrodigital.net\/en\/wp-json\/wp\/v2\/posts\/538343\/revisions"}],"predecessor-version":[{"id":538353,"href":"https:\/\/cerebrodigital.net\/en\/wp-json\/wp\/v2\/posts\/538343\/revisions\/538353"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/cerebrodigital.net\/en\/wp-json\/wp\/v2\/media\/538334"}],"wp:attachment":[{"href":"https:\/\/cerebrodigital.net\/en\/wp-json\/wp\/v2\/media?parent=538343"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cerebrodigital.net\/en\/wp-json\/wp\/v2\/categories?post=538343"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cerebrodigital.net\/en\/wp-json\/wp\/v2\/tags?post=538343"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}