{"id":386899,"date":"2025-11-18T05:48:24","date_gmt":"2025-11-18T05:48:24","guid":{"rendered":"https:\/\/www.europesays.com\/us\/386899\/"},"modified":"2025-11-18T05:48:24","modified_gmt":"2025-11-18T05:48:24","slug":"fda-clears-onward-medicals-spinal-cord-stimulator-for-home-use","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/us\/386899\/","title":{"rendered":"FDA clears Onward Medical&#8217;s spinal cord stimulator for home use"},"content":{"rendered":"<p class=\"author-bio\">O. Rose Broderick reports on the health policies and technologies that govern people with disabilities\u2019 lives. Before coming to STAT, she worked at WNYC\u2019s Radiolab and Scientific American, and her story debunking a bogus theory about transgender kids was nominated for a 2024 GLAAD Media Award. You can reach Rose on Signal at rosebroderick.11.<\/p>\n<p>The Food and Drug Administration has green-lit home use of a device that helps people with spinal cord injuries regain mobility and functioning. Onward Medical announced Monday that the company had received clearance to expand the use of its spinal cord stimulator outside of clinics.<\/p>\n<p>\u201cPeople living with [spinal cord injuries] will now be able to benefit from use of the ARC-EX System in the comfort and convenience of their own homes,\u201d said CEO Dave Marver in a press release.<\/p>\n<p>FDA first <a href=\"https:\/\/www.statnews.com\/2024\/12\/19\/spinal-cord-injury-onward-medical-arc-ex-fda-approval\/\" target=\"_blank\" rel=\"noopener\">cleared<\/a> the device for clinical use in 2024, after designating it a <a href=\"https:\/\/www.fda.gov\/medical-devices\/how-study-and-market-your-device\/breakthrough-devices-program\" target=\"_blank\" rel=\"noopener\">breakthrough device<\/a>. An earlier trial demonstrated that small zaps delivered on the skin and along the spine boosted hand and arm function in 72% of participants when paired with rehabilitative therapy. No serious adverse outcomes were reported.\u00a0<\/p>\n<p class=\"restricted-text\">STAT+ Exclusive Story<\/p>\n<p class=\"restricted-login\">Already have an account? <a href=\"https:\/\/www.statnews.com\/login\/\" data-stat-login=\"\" data-stat-paywall-cta=\"breaker login cta\" target=\"_blank\" rel=\"noopener\">Log in<\/a><\/p>\n<p>\t\t\t<img decoding=\"async\" class=\"restricted-content-breaker-bg\" src=\"https:\/\/www.europesays.com\/us\/wp-content\/uploads\/2025\/06\/stat-plus-breaker-bg.png\" alt=\"STAT+\"\/><\/p>\n<p>\t\t\t\t\t<a href=\"https:\/\/www.statnews.com\/stat-plus\/\" target=\"_blank\" rel=\"noopener\"><br \/>\n\t\t\t\t\t\t<img decoding=\"async\" class=\"stat-plus-logo\" src=\"https:\/\/www.statnews.com\/wp-content\/themes\/stat\/images\/stat-plus-logo-white.svg\" alt=\"STAT+\"\/><br \/>\n\t\t\t\t\t<\/a><\/p>\n<p>\t\t\t\tThis article is exclusive to STAT+ subscribers<br \/>\n\t\t\t\tUnlock this article \u2014 and get additional analysis of the technologies disrupting health care \u2014 by subscribing to STAT+.<\/p>\n<p class=\"restricted-content-breaker-wrapper-cta mobile\">Already have an account? <a href=\"https:\/\/www.statnews.com\/login\/\" data-stat-login=\"\" data-stat-paywall-cta=\"breaker login cta mobile\" target=\"_blank\" rel=\"noopener\">Log in<\/a><\/p>\n<p>\t\t\t\t\t\tIndividual plans<\/p>\n<p>\t\t\t\t\t\tGroup plans<\/p>\n<p>\t\t\t\t<a href=\"https:\/\/www.statnews.com\/stat-plus\/\" class=\"stat-button view-all\" data-stat-paywall-cta=\"breaker view all plans\" aria-label=\"View All Plans\" target=\"_blank\" rel=\"noopener\">View All Plans<\/a><\/p>\n<p class=\"restricted-content-text\">\n\t\t\t\t\t\tTo read the rest of this story subscribe to STAT+.\t\t\t\t\t<\/p>\n<p>\t\t\t\t\t<a href=\"https:\/\/www.statnews.com\/stat-plus\/\" class=\"stat-button restricted-button\" data-stat-paywall-cta=\"breaker subscribe cta 1\" target=\"_blank\" rel=\"noopener\">Subscribe<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"O. Rose Broderick reports on the health policies and technologies that govern people with disabilities\u2019 lives. Before coming&hellip;\n","protected":false},"author":3,"featured_media":386900,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[35],"tags":[7931,151,210,1141,1142,71434,67,132,68],"class_list":{"0":"post-386899","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-health-care","8":"tag-disability","9":"tag-fda","10":"tag-health","11":"tag-health-care","12":"tag-healthcare","13":"tag-medical-devices","14":"tag-united-states","15":"tag-unitedstates","16":"tag-us"},"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@us\/115569132396901128","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/386899","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/comments?post=386899"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/386899\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media\/386900"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media?parent=386899"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/categories?post=386899"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/tags?post=386899"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}