{"id":27418,"date":"2023-12-12T07:45:00","date_gmt":"2023-12-12T07:45:00","guid":{"rendered":"https:\/\/g-medtech.com\/news\/?p=27418"},"modified":"2025-08-18T03:02:31","modified_gmt":"2025-08-18T03:02:31","slug":"neuroone-receives-fda-approval-for-onerf-ablation-system","status":"publish","type":"post","link":"https:\/\/g-medtech.com\/news\/neuroone-receives-fda-approval-for-onerf-ablation-system\/","title":{"rendered":"NeuroOne Receives FDA Approval for OneRF\u2122 Ablation System"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/g-medtech.com\/database\/medtech-players\/index\/neuroone-medical-technologies\/\" target=\"_blank\" rel=\"noreferrer noopener\">NeuroOne Medical Technologies<\/a> has received U.S. FDA 510(k) clearance of OneRF\u2122 Ablation System for creation of radiofrequency (RF) lesions in nervous tissue for functional neurosurgical procedures.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The OneRF Ablation System is NeuroOne\u2019s first device with a therapeutic indication and its third FDA 510(k)-cleared device, boasting a full line of electrode technology to address patients requiring diagnostic brain mapping procedures as well as RF ablation using the same sEEG electrode. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">NeuroOne estimates the current brain ablation market to be at least $100M worldwide and growing rapidly, with the potential to grow multifold based on large addressable patient populations with unmet clinical needs.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">In addition to the OneRF Ablation System, NeuroOne\u2019s other FDA-cleared devices include the Evo\u00ae cortical and sEEG electrode product lines which are used primarily for recording electrical activity in the brain for less than 30 days.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>First FDA-cleared thin-film, sEEG-guided RF system capable of both recording electrical activity and ablating nervous tissue with the added benefit of temperature control<\/p>\n","protected":false},"author":2,"featured_media":27419,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"colormag_page_layout":"default_layout","footnotes":""},"categories":[7,25,677],"tags":[687],"class_list":["post-27418","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-americas","category-products-technologies","category-surgical","tag-fda"],"_links":{"self":[{"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/posts\/27418","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/comments?post=27418"}],"version-history":[{"count":3,"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/posts\/27418\/revisions"}],"predecessor-version":[{"id":34436,"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/posts\/27418\/revisions\/34436"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/media\/27419"}],"wp:attachment":[{"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/media?parent=27418"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/categories?post=27418"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/tags?post=27418"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}