{"id":8520,"date":"2025-11-20T23:02:22","date_gmt":"2025-11-20T23:02:22","guid":{"rendered":"https:\/\/mailitics.com\/index.php\/2025\/11\/20\/fda-approves-paradromics-bci-trial-for-speech-restoration\/"},"modified":"2025-11-20T23:02:22","modified_gmt":"2025-11-20T23:02:22","slug":"fda-approves-paradromics-bci-trial-for-speech-restoration","status":"publish","type":"post","link":"https:\/\/mailitics.com\/index.php\/2025\/11\/20\/fda-approves-paradromics-bci-trial-for-speech-restoration\/","title":{"rendered":"STAT+: FDA approves Paradromics\u2019 brain-computer interface trial for speech restoration"},"content":{"rendered":"<p>    STAT+: FDA approves Paradromics\u2019 brain-computer interface trial for speech restoration<br \/>\n \t<BR><br \/>\n<BR><\/BR><br \/>\n    <!-- no image --><br \/>\n \t<BR><br \/>\n<BR><\/BR><\/p>\n<div>\n<p>Paradromics announced Thursday that the Food and Drug Administration approved a clinical study to evaluate whether the company\u2019s brain-computer interface for speech restoration is safe and capable of providing the ability to communicate via text or synthesized speech to someone with paralysis.\u00a0<\/p>\n<p>The Austin-based company is one of a handful of startups \u2014 including Elon Musk\u2019s Neuralink, Synchron, and Precision Neuroscience, among others \u2014 that have transformed brain-computer interfaces from an obscure academic niche to a promising neurotechnology that Morgan Stanley recently <a href=\"https:\/\/finance.yahoo.com\/news\/inside-a-400-billion-bet-on-the-brain-computer-interface-revolution-150057794.html\">valued<\/a> at $400 billion.\u00a0<\/p>\n<p>The FDA nod is the latest step forward for Paradromics, which has received multiple <a href=\"https:\/\/www.statnews.com\/feature\/stat-plus\/breakthrough-device-designation-fda-tracker\/\">breakthrough device<\/a> designations but is racing to catch up to Synchron and Neuralink. Their clinical trials already have regulatory approval, though Paradromics CEO and co-founder Matt Angle is not shy about criticizing the competitors\u2019 devices, including a lengthy October blog post titled, \u201c<a href=\"https:\/\/www.paradromics.com\/insights\/neuralink-implant\">Neuralink device limitation<\/a>.\u201d<\/p>\n<p><a href=\"https:\/\/www.statnews.com\/2025\/11\/20\/fda-approves-paradromics-bci-trial-for-speech-restoration\/?utm_campaign=rss\">Continue to STAT+ to read the full story\u2026<\/a><\/p>\n<\/div>\n<p> \t<BR><br \/>\n <BR><\/BR><br \/>\n    O. Rose Broderick<br \/>\n \t<BR><br \/>\n<BR><\/BR><br \/>\n<a href=\"https:\/\/www.statnews.com\/2025\/11\/20\/fda-approves-paradromics-bci-trial-for-speech-restoration\/?utm_campaign=rss\">Go to statnews<\/a><br \/>\n \t<BR><br \/>\n <BR><\/BR><\/p>\n","protected":false},"excerpt":{"rendered":"<p>STAT+: FDA approves Paradromics\u2019 brain-computer interface trial for speech restoration Paradromics announced Thursday that the Food and Drug Administration approved a clinical study to evaluate whether the company\u2019s brain-computer interface for speech restoration is safe and capable of providing the ability to communicate via text or synthesized speech to someone with paralysis.\u00a0 The Austin-based company [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2238,2217,2956,2152],"tags":[2150],"class_list":["post-8520","post","type-post","status-publish","format-standard","hentry","category-disability","category-health-tech","category-neuroscience","category-stat","tag-statnews"],"_links":{"self":[{"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/posts\/8520"}],"collection":[{"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/comments?post=8520"}],"version-history":[{"count":0,"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/posts\/8520\/revisions"}],"wp:attachment":[{"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/media?parent=8520"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/categories?post=8520"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/tags?post=8520"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}