{"id":2744,"date":"2025-12-13T08:53:27","date_gmt":"2025-12-13T08:53:27","guid":{"rendered":"https:\/\/whmnews.ir\/En\/?p=2744"},"modified":"2025-12-13T08:53:27","modified_gmt":"2025-12-13T08:53:27","slug":"us-fda-approves-first-at-home-device-for-depression","status":"publish","type":"post","link":"https:\/\/whmnews.ir\/En\/index.php\/2025\/12\/13\/us-fda-approves-first-at-home-device-for-depression\/","title":{"rendered":"US FDA Approves First At-Home Device for Depression"},"content":{"rendered":"<p style=\"text-align: justify;\"><strong>US FDA Approves First At-Home Device for Depression<\/strong><\/p>\n<p style=\"text-align: justify;\">The U.S. Food and \u200cDrug \u200bAdministration has approved Flow Neuroscience&#8217;s \u200cat-home brain stimulation device to treat depression, offering an alternative \u200bto typical antidepressants that can cause side effects with long-term use, the company said on \u200dThursday.<\/p>\n<p style=\"text-align: justify;\">Depression rates in the U.S. \u200bhave surged 60% over the past decade, affecting more than 20 million adults, \u200baccording to \u2060the Centers for Disease Control and Prevention.<\/p>\n<p style=\"text-align: justify;\">Flow&#8217;s FL-100 delivers a gentle electrical current to the part of the brain that regulates mood and is designed for home use under remote supervision. It is the first such device to be approved \u200cin the U.S.<\/p>\n<p style=\"text-align: justify;\">The device is cleared to treat moderate to severe major depressive \u200bdisorders in \u200cadults aged 18 and \u200dolder, as \u2060a standalone treatment or alongside other treatments, who are not considered resistant to medication.<\/p>\n<p style=\"text-align: justify;\">Flow plans to launch the device in the U.S. in the second quarter of 2026 as a prescription-only treatment.<\/p>\n<p style=\"text-align: justify;\">The company&#8217;s CEO Erin Lee told Reuters the company is targeting a U.S. retail price between $500 and $800. Flow is negotiating with insurance payers and expects to announce coverage \u200bpartnerships in early 2026, Lee added.<\/p>\n<p style=\"text-align: justify;\">The device has been used by over 55,000 people in Europe, the UK, Switzerland and Hong Kong, Flow said.<\/p>\n<p style=\"text-align: justify;\">The FDA&#8217;s approval was based on a mid-stage study in which 58% of patients achieved remission after 10 weeks, including many who were already on medication or in therapy. Among global users, 77% reported symptom improvement within three weeks, the company said.<\/p>\n<p style=\"text-align: justify;\">Patients typically follow a 12-week course, starting with five sessions per week for three weeks, then tapering to two or three \u200bsessions weekly for the remaining nine weeks. Each session lasts 30 minutes.<\/p>\n<p style=\"text-align: justify;\">Side effects are generally mild and temporary, including skin irritation, headache and tingling sensations at electrode sites, Flow said, adding skin burns have occurred when the \u200bdevice&#8217;s pads were reused or dried out.<\/p>\n<p style=\"text-align: justify;\">\n<p style=\"text-align: justify;\">\n","protected":false},"excerpt":{"rendered":"<p>US FDA Approves First At-Home Device for Depression The U.S. Food and \u200cDrug \u200bAdministration has approved Flow Neuroscience&#8217;s \u200cat-home brain stimulation device to treat depression, offering an alternative \u200bto typical antidepressants that can cause side effects with long-term use, the company said on \u200dThursday. Depression rates in the U.S. \u200bhave surged 60% over the past [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":2745,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[11],"tags":[906],"class_list":{"0":"post-2744","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-technology-health","8":"tag-us-fda-approves-first-at-home-device-for-depression"},"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v24.1 (Yoast SEO v24.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>US FDA Approves First At-Home Device for Depression - whmnews<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/whmnews.ir\/En\/index.php\/2025\/12\/13\/us-fda-approves-first-at-home-device-for-depression\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"US FDA Approves First At-Home Device for Depression\" \/>\n<meta property=\"og:description\" content=\"US FDA Approves First At-Home Device for Depression The U.S. Food and \u200cDrug \u200bAdministration has approved Flow Neuroscience&#8217;s \u200cat-home brain stimulation device to treat depression, offering an alternative \u200bto typical antidepressants that can cause side effects with long-term use, the company said on \u200dThursday. Depression rates in the U.S. \u200bhave surged 60% over the past [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/whmnews.ir\/En\/index.php\/2025\/12\/13\/us-fda-approves-first-at-home-device-for-depression\/\" \/>\n<meta property=\"og:site_name\" content=\"whmnews\" \/>\n<meta property=\"article:published_time\" content=\"2025-12-13T08:53:27+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/whmnews.ir\/En\/wp-content\/uploads\/2025\/12\/US-FDA-Approves-First-At-Home-Device-for-Depression.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"300\" \/>\n\t<meta property=\"og:image:height\" content=\"195\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Roza News\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Roza News\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/whmnews.ir\/En\/index.php\/2025\/12\/13\/us-fda-approves-first-at-home-device-for-depression\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/whmnews.ir\/En\/index.php\/2025\/12\/13\/us-fda-approves-first-at-home-device-for-depression\/\"},\"author\":{\"name\":\"Roza News\",\"@id\":\"https:\/\/whmnews.ir\/En\/#\/schema\/person\/77fef232f03e0a43eb2c2ecc12e4de2e\"},\"headline\":\"US FDA Approves First At-Home Device for Depression\",\"datePublished\":\"2025-12-13T08:53:27+00:00\",\"dateModified\":\"2025-12-13T08:53:27+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/whmnews.ir\/En\/index.php\/2025\/12\/13\/us-fda-approves-first-at-home-device-for-depression\/\"},\"wordCount\":329,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/whmnews.ir\/En\/#organization\"},\"image\":{\"@id\":\"https:\/\/whmnews.ir\/En\/index.php\/2025\/12\/13\/us-fda-approves-first-at-home-device-for-depression\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/whmnews.ir\/En\/wp-content\/uploads\/2025\/12\/US-FDA-Approves-First-At-Home-Device-for-Depression.jpg\",\"keywords\":[\"US FDA Approves First At-Home Device for Depression\"],\"articleSection\":[\"Technology &amp; Health\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/whmnews.ir\/En\/index.php\/2025\/12\/13\/us-fda-approves-first-at-home-device-for-depression\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/whmnews.ir\/En\/index.php\/2025\/12\/13\/us-fda-approves-first-at-home-device-for-depression\/\",\"url\":\"https:\/\/whmnews.ir\/En\/index.php\/2025\/12\/13\/us-fda-approves-first-at-home-device-for-depression\/\",\"name\":\"US FDA Approves First At-Home Device for Depression - whmnews\",\"isPartOf\":{\"@id\":\"https:\/\/whmnews.ir\/En\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/whmnews.ir\/En\/index.php\/2025\/12\/13\/us-fda-approves-first-at-home-device-for-depression\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/whmnews.ir\/En\/index.php\/2025\/12\/13\/us-fda-approves-first-at-home-device-for-depression\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/whmnews.ir\/En\/wp-content\/uploads\/2025\/12\/US-FDA-Approves-First-At-Home-Device-for-Depression.jpg\",\"datePublished\":\"2025-12-13T08:53:27+00:00\",\"dateModified\":\"2025-12-13T08:53:27+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/whmnews.ir\/En\/index.php\/2025\/12\/13\/us-fda-approves-first-at-home-device-for-depression\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/whmnews.ir\/En\/index.php\/2025\/12\/13\/us-fda-approves-first-at-home-device-for-depression\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/whmnews.ir\/En\/index.php\/2025\/12\/13\/us-fda-approves-first-at-home-device-for-depression\/#primaryimage\",\"url\":\"https:\/\/whmnews.ir\/En\/wp-content\/uploads\/2025\/12\/US-FDA-Approves-First-At-Home-Device-for-Depression.jpg\",\"contentUrl\":\"https:\/\/whmnews.ir\/En\/wp-content\/uploads\/2025\/12\/US-FDA-Approves-First-At-Home-Device-for-Depression.jpg\",\"width\":300,\"height\":195},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/whmnews.ir\/En\/index.php\/2025\/12\/13\/us-fda-approves-first-at-home-device-for-depression\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/whmnews.ir\/En\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"US FDA Approves First At-Home Device for Depression\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/whmnews.ir\/En\/#website\",\"url\":\"https:\/\/whmnews.ir\/En\/\",\"name\":\"whmnews\",\"description\":\"\",\"publisher\":{\"@id\":\"https:\/\/whmnews.ir\/En\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/whmnews.ir\/En\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/whmnews.ir\/En\/#organization\",\"name\":\"World Health and Medicine News\",\"url\":\"https:\/\/whmnews.ir\/En\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/whmnews.ir\/En\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/whmnews.ir\/En\/wp-content\/uploads\/2024\/12\/logo-whmnews-1.png\",\"contentUrl\":\"https:\/\/whmnews.ir\/En\/wp-content\/uploads\/2024\/12\/logo-whmnews-1.png\",\"width\":387,\"height\":181,\"caption\":\"World Health and Medicine News\"},\"image\":{\"@id\":\"https:\/\/whmnews.ir\/En\/#\/schema\/logo\/image\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\/\/whmnews.ir\/En\/#\/schema\/person\/77fef232f03e0a43eb2c2ecc12e4de2e\",\"name\":\"Roza News\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/whmnews.ir\/En\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/b2b23fed0bb80c5fe651202e69a75e2b079e147751aa945606f536a5bd8e64ef?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/b2b23fed0bb80c5fe651202e69a75e2b079e147751aa945606f536a5bd8e64ef?s=96&d=mm&r=g\",\"caption\":\"Roza News\"},\"sameAs\":[\"http:\/\/whmnews\"],\"url\":\"https:\/\/whmnews.ir\/En\/index.php\/author\/journalist\/\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"US FDA Approves First At-Home Device for Depression - whmnews","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/whmnews.ir\/En\/index.php\/2025\/12\/13\/us-fda-approves-first-at-home-device-for-depression\/","og_locale":"en_US","og_type":"article","og_title":"US FDA Approves First At-Home Device for Depression","og_description":"US FDA Approves First At-Home Device for Depression The U.S. Food and \u200cDrug \u200bAdministration has approved Flow Neuroscience&#8217;s \u200cat-home brain stimulation device to treat depression, offering an alternative \u200bto typical antidepressants that can cause side effects with long-term use, the company said on \u200dThursday. Depression rates in the U.S. \u200bhave surged 60% over the past [&hellip;]","og_url":"https:\/\/whmnews.ir\/En\/index.php\/2025\/12\/13\/us-fda-approves-first-at-home-device-for-depression\/","og_site_name":"whmnews","article_published_time":"2025-12-13T08:53:27+00:00","og_image":[{"width":300,"height":195,"url":"https:\/\/whmnews.ir\/En\/wp-content\/uploads\/2025\/12\/US-FDA-Approves-First-At-Home-Device-for-Depression.jpg","type":"image\/jpeg"}],"author":"Roza News","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Roza News","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/whmnews.ir\/En\/index.php\/2025\/12\/13\/us-fda-approves-first-at-home-device-for-depression\/#article","isPartOf":{"@id":"https:\/\/whmnews.ir\/En\/index.php\/2025\/12\/13\/us-fda-approves-first-at-home-device-for-depression\/"},"author":{"name":"Roza News","@id":"https:\/\/whmnews.ir\/En\/#\/schema\/person\/77fef232f03e0a43eb2c2ecc12e4de2e"},"headline":"US FDA Approves First At-Home Device for Depression","datePublished":"2025-12-13T08:53:27+00:00","dateModified":"2025-12-13T08:53:27+00:00","mainEntityOfPage":{"@id":"https:\/\/whmnews.ir\/En\/index.php\/2025\/12\/13\/us-fda-approves-first-at-home-device-for-depression\/"},"wordCount":329,"commentCount":0,"publisher":{"@id":"https:\/\/whmnews.ir\/En\/#organization"},"image":{"@id":"https:\/\/whmnews.ir\/En\/index.php\/2025\/12\/13\/us-fda-approves-first-at-home-device-for-depression\/#primaryimage"},"thumbnailUrl":"https:\/\/whmnews.ir\/En\/wp-content\/uploads\/2025\/12\/US-FDA-Approves-First-At-Home-Device-for-Depression.jpg","keywords":["US FDA Approves First At-Home Device for Depression"],"articleSection":["Technology &amp; Health"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/whmnews.ir\/En\/index.php\/2025\/12\/13\/us-fda-approves-first-at-home-device-for-depression\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/whmnews.ir\/En\/index.php\/2025\/12\/13\/us-fda-approves-first-at-home-device-for-depression\/","url":"https:\/\/whmnews.ir\/En\/index.php\/2025\/12\/13\/us-fda-approves-first-at-home-device-for-depression\/","name":"US FDA Approves First At-Home Device for Depression - whmnews","isPartOf":{"@id":"https:\/\/whmnews.ir\/En\/#website"},"primaryImageOfPage":{"@id":"https:\/\/whmnews.ir\/En\/index.php\/2025\/12\/13\/us-fda-approves-first-at-home-device-for-depression\/#primaryimage"},"image":{"@id":"https:\/\/whmnews.ir\/En\/index.php\/2025\/12\/13\/us-fda-approves-first-at-home-device-for-depression\/#primaryimage"},"thumbnailUrl":"https:\/\/whmnews.ir\/En\/wp-content\/uploads\/2025\/12\/US-FDA-Approves-First-At-Home-Device-for-Depression.jpg","datePublished":"2025-12-13T08:53:27+00:00","dateModified":"2025-12-13T08:53:27+00:00","breadcrumb":{"@id":"https:\/\/whmnews.ir\/En\/index.php\/2025\/12\/13\/us-fda-approves-first-at-home-device-for-depression\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/whmnews.ir\/En\/index.php\/2025\/12\/13\/us-fda-approves-first-at-home-device-for-depression\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/whmnews.ir\/En\/index.php\/2025\/12\/13\/us-fda-approves-first-at-home-device-for-depression\/#primaryimage","url":"https:\/\/whmnews.ir\/En\/wp-content\/uploads\/2025\/12\/US-FDA-Approves-First-At-Home-Device-for-Depression.jpg","contentUrl":"https:\/\/whmnews.ir\/En\/wp-content\/uploads\/2025\/12\/US-FDA-Approves-First-At-Home-Device-for-Depression.jpg","width":300,"height":195},{"@type":"BreadcrumbList","@id":"https:\/\/whmnews.ir\/En\/index.php\/2025\/12\/13\/us-fda-approves-first-at-home-device-for-depression\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/whmnews.ir\/En\/"},{"@type":"ListItem","position":2,"name":"US FDA Approves First At-Home Device for Depression"}]},{"@type":"WebSite","@id":"https:\/\/whmnews.ir\/En\/#website","url":"https:\/\/whmnews.ir\/En\/","name":"whmnews","description":"","publisher":{"@id":"https:\/\/whmnews.ir\/En\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/whmnews.ir\/En\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/whmnews.ir\/En\/#organization","name":"World Health and Medicine News","url":"https:\/\/whmnews.ir\/En\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/whmnews.ir\/En\/#\/schema\/logo\/image\/","url":"https:\/\/whmnews.ir\/En\/wp-content\/uploads\/2024\/12\/logo-whmnews-1.png","contentUrl":"https:\/\/whmnews.ir\/En\/wp-content\/uploads\/2024\/12\/logo-whmnews-1.png","width":387,"height":181,"caption":"World Health and Medicine News"},"image":{"@id":"https:\/\/whmnews.ir\/En\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/whmnews.ir\/En\/#\/schema\/person\/77fef232f03e0a43eb2c2ecc12e4de2e","name":"Roza News","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/whmnews.ir\/En\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/b2b23fed0bb80c5fe651202e69a75e2b079e147751aa945606f536a5bd8e64ef?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/b2b23fed0bb80c5fe651202e69a75e2b079e147751aa945606f536a5bd8e64ef?s=96&d=mm&r=g","caption":"Roza News"},"sameAs":["http:\/\/whmnews"],"url":"https:\/\/whmnews.ir\/En\/index.php\/author\/journalist\/"}]}},"_links":{"self":[{"href":"https:\/\/whmnews.ir\/En\/index.php\/wp-json\/wp\/v2\/posts\/2744","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/whmnews.ir\/En\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/whmnews.ir\/En\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/whmnews.ir\/En\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/whmnews.ir\/En\/index.php\/wp-json\/wp\/v2\/comments?post=2744"}],"version-history":[{"count":1,"href":"https:\/\/whmnews.ir\/En\/index.php\/wp-json\/wp\/v2\/posts\/2744\/revisions"}],"predecessor-version":[{"id":2746,"href":"https:\/\/whmnews.ir\/En\/index.php\/wp-json\/wp\/v2\/posts\/2744\/revisions\/2746"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/whmnews.ir\/En\/index.php\/wp-json\/wp\/v2\/media\/2745"}],"wp:attachment":[{"href":"https:\/\/whmnews.ir\/En\/index.php\/wp-json\/wp\/v2\/media?parent=2744"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/whmnews.ir\/En\/index.php\/wp-json\/wp\/v2\/categories?post=2744"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/whmnews.ir\/En\/index.php\/wp-json\/wp\/v2\/tags?post=2744"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}