{"id":1143658,"date":"2023-05-25T20:15:04","date_gmt":"2023-05-26T00:15:04","guid":{"rendered":"https:\/\/www.prime-wow.com\/?p=1143658"},"modified":"2023-05-25T20:15:04","modified_gmt":"2023-05-26T00:15:04","slug":"neuralink-receives-fda-clearance-to-begin-human-trials-of-its-brain-computer-interface","status":"publish","type":"post","link":"https:\/\/www.prime-wow.com\/?p=1143658","title":{"rendered":"Neuralink receives FDA clearance to begin human trials of its brain-computer interface"},"content":{"rendered":"<p>Turns out <a data-i13n=\"cpos:1;pos:1\" href=\"https:\/\/www.engadget.com\/neuralink-ceo-elon-musk-expects-human-trials-within-six-months-025416421.html\">Elon Musk&#8217;s FDA prediction<\/a> was only off by about a month. After reportedly denying the company&#8217;s overtures in March, <a data-i13n=\"cpos:2;pos:1\" href=\"https:\/\/www.reuters.com\/science\/elon-musks-neuralink-gets-us-fda-approval-human-clinical-study-brain-implants-2023-05-25\/\">the FDA approved Neuralink&#8217;s application<\/a> to begin human trials of its prototype Link brain-computer interface (BCI) on Thursday.\u00a0<\/p>\n<p>Founded in 2016, Neuralink aims to commercialize BCIs in wide-ranging medical and therapeutic applications \u2014 from stroke and spinal cord injury (SCI) rehabilitation, to neural prosthetic controls, to the capacity &#8220;<a data-i13n=\"cpos:3;pos:1\" href=\"https:\/\/sociable.co\/technology\/futures-gonna-be-weird-musk-memories-downloaded-new-body-robot\/\">to rewind memories or download them into robots<\/a>,&#8221; Neuralink CEO Elon Musk promised in 2020. BCIs essentially translate the analog electrical impulses of your brain (monitoring it using hair-thin electrodes delicately threaded into that grey matter) into the digital 1&#8217;s and 0&#8217;s that computers understand. Since that BCI needs to be surgically installed in a patient&#8217;s noggin, the FDA \u2014 which regulates such technologies \u2014 requires that companies conduct rigorous safety testing before giving its approval for commercial use.\u00a0<\/p>\n<p><span id=\"end-legacy-contents\" \/><\/p>\n<p>In March, the FDA rejected Neuralink&#8217;s application to begin human trials reportedly in part due to <a data-i13n=\"cpos:4;pos:1\" href=\"https:\/\/www.engadget.com\/neuralink-federal-investigation-animal-testing-071953787.html\">all the test animals that kept dying after having the prototype BCI implanted<\/a>. According to internal documents acquired by <a data-i13n=\"cpos:5;pos:1\" href=\"https:\/\/www.reuters.com\/technology\/musks-neuralink-faces-federal-probe-employee-backlash-over-animal-tests-2022-12-05\/?utm_source=twitter&amp;utm_medium=Social\"><em>Reuters<\/em><\/a><em>\u00a0<\/em>in December, more than 1,500 animals had been killed in the development of the Neuralink BCI since 2018. The US Department of Agriculture&#8217;s (USDA) Inspector General has <a data-i13n=\"cpos:6;pos:1\" href=\"https:\/\/www.reuters.com\/world\/us\/probe-musks-neuralink-scrutinize-long-criticized-us-animal-welfare-regulator-2022-12-19\/\">since launched an investigation<\/a> into those allegations.\u00a0\u00a0<\/p>\n<p>The FDA&#8217;s reticence was also born from concerns about the design and function of the interface when implanted in humans. &#8220;The agency\u2019s major safety concerns involved the device\u2019s lithium battery; the potential for the implant\u2019s 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,&#8221; current and former Neuralink employees told <em>Reuters<\/em> in March.<\/p>\n<p>While Neuralink has obtained FDA approval to begin its study, the company is not yet seeking volunteers. 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,&#8221; <a data-i13n=\"cpos:7;pos:1\" href=\"https:\/\/twitter.com\/neuralink\/status\/1661857379460468736\">Neuralink Tweeted on Thursday<\/a>. &#8220;Recruitment is not yet open for our clinical trial.&#8221;\u00a0\u00a0<\/p>\n<p>This article originally appeared on Engadget at https:\/\/www.engadget.com\/neuralink-receives-fda-clearance-to-begin-human-trials-of-its-brain-computer-interface-001504243.html?src=rss&#013;<br \/>\n&#013;<br \/>\nSource: Engadget &#8211; <a href=\"https:\/\/www.engadget.com\/neuralink-receives-fda-clearance-to-begin-human-trials-of-its-brain-computer-interface-001504243.html?src=rss\" target=\"_blank\" rel=\"noopener\">Neuralink receives FDA clearance to begin human trials of its brain-computer interface<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Turns out Elon Musk&#8217;s FDA prediction was only off by about a month. After reportedly denying the company&#8217;s overtures in March, the FDA approved Neuralink&#8217;s application to begin human trials of its prototype Link brain-computer interface (BCI) on Thursday.\u00a0 Founded &hellip; <a href=\"https:\/\/www.prime-wow.com\/?p=1143658\">Continue reading <span class=\"meta-nav\">&rarr;<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"ngg_post_thumbnail":0,"footnotes":""},"categories":[99,110],"tags":[98],"class_list":["post-1143658","post","type-post","status-publish","format-standard","hentry","category-engadget","category-unfiltered-rss","tag-engadget"],"_links":{"self":[{"href":"https:\/\/www.prime-wow.com\/index.php?rest_route=\/wp\/v2\/posts\/1143658","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.prime-wow.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.prime-wow.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.prime-wow.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.prime-wow.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=1143658"}],"version-history":[{"count":0,"href":"https:\/\/www.prime-wow.com\/index.php?rest_route=\/wp\/v2\/posts\/1143658\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.prime-wow.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1143658"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.prime-wow.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=1143658"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.prime-wow.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=1143658"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}