{"id":29837,"date":"2025-01-06T10:06:18","date_gmt":"2025-01-06T09:06:18","guid":{"rendered":"https:\/\/ggba.swiss\/?p=29837"},"modified":"2025-01-06T10:13:00","modified_gmt":"2025-01-06T09:13:00","slug":"onward-medical-receives-fda-authorization-for-its-spinal-cord-stimulation-system","status":"publish","type":"post","link":"https:\/\/ggba.swiss\/en\/onward-medical-receives-fda-authorization-for-its-spinal-cord-stimulation-system\/","title":{"rendered":"ONWARD Medical receives FDA authorization for its spinal cord stimulation system"},"content":{"rendered":"\n<p><a href=\"https:\/\/www.onwd.com\/\">ONWARD Medical<\/a>, a leader in spinal cord stimulation therapies, has received FDA de novo classification and authorization to market its <a href=\"https:\/\/www.onwd.com\/therapy\/arc-ex\/\">ARC-EX System<\/a> in the United States. This approval represents a breakthrough in the treatment of chronic spinal cord injuries, offering the first FDA-approved technology shown to improve hand strength and sensation for individuals with long-term SCI.<\/p>\n\n\n\n<p>The ARC-EX System provides programmed electrical stimulation to the spinal cord through electrodes placed on the back of the neck, delivering therapy in a completely non-invasive manner. Unlike traditional spinal cord stimulation devices that require surgery, the ARC-EX System consists of an external stimulator and wireless programmer, allowing parameters to be tailored to each patient\u2019s needs.<\/p>\n\n\n\n<p>The ARC-EX System\u2019s approval follows the success of the Up-LIFT clinical study, published in Nature Medicine. The study demonstrated that 90% of participants experienced improved strength or function, and 87% reported a higher quality of life. Benefits, including reduced spasm frequency, improved sleep, and enhanced sensation, were observed in participants with injuries as long as 34 years ago.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">A new standard in spinal cord therapy<\/h4>\n\n\n\n<p>\u201cThis authorization marks the beginning of a new era for individuals living with chronic spinal cord injuries,\u201d said Dave Marver, CEO of ONWARD Medical. \u201cThe ARC-EX System represents a critical step forward in restoring independence for those affected by paralysis and other movement disabilities.\u201d<\/p>\n\n\n\n<p>Authorized under the <a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-submissions-selecting-and-preparing-correct-submission\/de-novo-classification-request\">FDA\u2019s De Novo pathway<\/a>, the ARC-EX System is classified as a low-to-medium-risk device with no prior predicate, ensuring safety and effectiveness through rigorous evaluation.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>ONWARD Medical has achieved a significant milestone with FDA de novo classification and market authorization for its non-invasive ARC-EX System, the first technology approved to enhance hand strength and sensation after chronic spinal cord injury.<\/p>\n","protected":false},"author":6,"featured_media":29838,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"mc4wp_mailchimp_campaign":[],"footnotes":""},"categories":[833],"tags":[963,926,940,902],"class_list":["post-29837","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-life-science","tag-medical-devices","tag-medtech","tag-neuroscience","tag-personalized-medicine"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ONWARD Medical&#039;s ARC-EX system receives FDA authorization<\/title>\n<meta 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