{"id":806243,"date":"2022-04-18T04:35:38","date_gmt":"2022-04-18T08:35:38","guid":{"rendered":"https:\/\/www.statnews.com\/?p=806243"},"modified":"2025-03-10T22:59:16","modified_gmt":"2025-03-11T02:59:16","slug":"breakthrough-device-designation-fda-tracker","status":"publish","type":"post","link":"https:\/\/www.statnews.com\/feature\/stat-plus\/breakthrough-device-designation-fda-tracker\/","title":{"rendered":"An authoritative database of FDA&#8217;s fast-tracked medical devices"},"content":{"rendered":"<p><script type=\"text\/javascript\" src=\"https:\/\/pym.nprapps.org\/pym.v1.min.js\"><\/script><\/p>\n<p>The world of medical devices is growing more sprawling every day. Some promising novel ideas can take longer to wind their way through regulatory review and get to patients \u2014 so since 2017, the Food and Drug Administration has deployed a program for what it calls \u201cbreakthrough devices\u201d to speed the process.<\/p>\n<p>The program has surged significantly in size, but <a href=\"https:\/\/www.statnews.com\/2022\/04\/18\/fda-breakthrough-device-designation-investigation\/\">its implementation remains largely shielded<\/a> from the public eye. So STAT identified as many breakthrough-designated devices as possible \u2014 more than two-thirds of the total to date \u2014 and created a tool to help users understand the FDA\u2019s approach. You can filter by conditions, clinical areas, manufacturer, market pathway, and authorization status.<\/p>\n<p>We\u2019ll be regularly updating the list with new designations as they\u2019re made public. Because the FDA doesn\u2019t disclose breakthrough status except for authorized devices, STAT\u2019s database is sourced directly from companies that have chosen to publicly share it. Keep in mind that b<span style=\"font-weight: 400;\">reakthroughs aren\u2019t guaranteed to live up to their name \u2014 instead, the FDA\u2019s designation indicates that a device, among other criteria, could one day prove to be \u201cmore effective\u201d at treating or diagnosing deadly and debilitating conditions. Note that a<\/span> breakthrough designation has no bearing on whether a device ultimately may be authorized or whether it proves to be more effective than alternatives.<\/p>","protected":false},"excerpt":{"rendered":"<p>The FDA&#8217;s Breakthrough Device program is growing rapidly, but remains secretive. So STAT built a comprehensive database searchable by indication, manufacturer, regulatory pathway, and more. <\/p>\n","protected":false},"author":760,"featured_media":1255950,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"image","meta":{"stat_display_restriction_not_latest":false,"stat_featured_image_caption":"","stat_featured_image_nocrop":true,"stat_featured_image_focal_point":{"x":0.5,"y":0.5},"stat_article_wordmark_img":[],"stat_article_wordmark_url":"","stat_article_wordmark_height":"125px","stat_article_wordmark_enable":false,"stat_article_subheadline":"","stat_paywall_restrict":true,"footnotes":"","stat_article_enhanced_byline":"","stat_article_newsletter_id":"","stat_article_header_color_scheme":"","_yoast_wpseo_primary_category":11086,"stat_paywall_move_flag":0},"categories":[11086],"tags":[8894,8620,11102],"authors":[204691,199140,200054,198971],"class_list":["post-806243","post","type-post","status-publish","format-image","has-post-thumbnail","hentry","category-health-tech","tag-artificial-intelligence","tag-government-agencies","tag-health-tech","post_format-post-format-image","feature-stat-plus"],"featured_image_src":"https:\/\/www.statnews.com\/wp-content\/uploads\/2022\/04\/BreakthroughDeviceTracker_Wordpress_FeaturedImage-1024x260.jpg","coauthors":[{"avatar":"<img width=\"80\" height=\"80\" src=\"https:\/\/www.statnews.com\/wp-content\/uploads\/2023\/01\/lizzy-lawrence-avatar-round-80x80.png\" class=\"avatar\" alt=\"Lizzy Lawrence\" loading=\"lazy\" sizes=\"auto, (max-width: 80px) 100vw, 80px\" decoding=\"async\" srcset=\"https:\/\/www.statnews.com\/wp-content\/uploads\/2023\/01\/lizzy-lawrence-avatar-round-80x80.png 80w, https:\/\/www.statnews.com\/wp-content\/uploads\/2023\/01\/lizzy-lawrence-avatar-round-328x328.png 328w, https:\/\/www.statnews.com\/wp-content\/uploads\/2023\/01\/lizzy-lawrence-avatar-round-500x500.png 500w, https:\/\/www.statnews.com\/wp-content\/uploads\/2023\/01\/lizzy-lawrence-avatar-round-576x576.png 576w, https:\/\/www.statnews.com\/wp-content\/uploads\/2023\/01\/lizzy-lawrence-avatar-round-160x160.png 160w, https:\/\/www.statnews.com\/wp-content\/uploads\/2023\/01\/lizzy-lawrence-avatar-round.png 600w\" \/>","display_name":"Lizzy Lawrence","author_page":"https:\/\/www.statnews.com\/staff\/lizzy-lawrence\/","first_name":"Lizzy","title":"FDA Reporter","bio":"Lizzy Lawrence leads STAT's coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53.","email_address":"lizzy.lawrence@statnews.com","email_url":"mailto:lizzy.lawrence@statnews.com","twitter_url":"https:\/\/x.com\/LizzyLaw_","twitter_handle":"@LizzyLaw_","facebook_url":"","linkedin_url":"https:\/\/www.linkedin.com\/in\/lizzy-lawrence1\/","web_url":"","bluesky_url":"https:\/\/bsky.app\/profile\/lizzylawrence.bsky.social","bluesky_handle":"@lizzylawrence.bsky.social"},{"avatar":"<img width=\"80\" height=\"80\" src=\"https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/katie-p-avatar-small-80x80.png\" class=\"avatar\" alt=\"Katie Palmer\" loading=\"lazy\" sizes=\"auto, (max-width: 80px) 100vw, 80px\" decoding=\"async\" srcset=\"https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/katie-p-avatar-small-80x80.png 80w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/katie-p-avatar-small-328x328.png 328w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/katie-p-avatar-small-500x500.png 500w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/katie-p-avatar-small-640x640.png 640w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/katie-p-avatar-small-576x576.png 576w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/katie-p-avatar-small-160x160.png 160w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/katie-p-avatar-small-645x645.png 645w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/katie-p-avatar-small.png 700w\" \/>","display_name":"Katie Palmer","author_page":"https:\/\/www.statnews.com\/staff\/katie-palmer\/","first_name":"Katie","title":"Health Tech Correspondent","bio":"Katie Palmer covers telehealth, clinical artificial intelligence, and the health data economy \u2014 with an emphasis on the impacts of digital health care for patients, providers, and businesses. You can reach Katie on Signal at palmer.01.","email_address":"katie.palmer@statnews.com","email_url":"mailto:katie.palmer@statnews.com","twitter_url":"https:\/\/x.com\/KatieMPalmer","twitter_handle":"@KatieMPalmer","facebook_url":"","linkedin_url":"","web_url":"","bluesky_url":"","bluesky_handle":""},{"avatar":"<img width=\"80\" height=\"80\" src=\"https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/03\/emory-avatar-small-80x80.png\" class=\"avatar\" alt=\"J. Emory Parker\" loading=\"lazy\" sizes=\"auto, (max-width: 80px) 100vw, 80px\" decoding=\"async\" srcset=\"https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/03\/emory-avatar-small-80x80.png 80w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/03\/emory-avatar-small-328x328.png 328w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/03\/emory-avatar-small-500x500.png 500w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/03\/emory-avatar-small-576x576.png 576w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/03\/emory-avatar-small-160x160.png 160w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/03\/emory-avatar-small.png 600w\" \/>","display_name":"J. Emory Parker","author_page":"https:\/\/www.statnews.com\/staff\/emory-parker\/","first_name":"J. Emory","title":"Data Editor","bio":"Emory is the data editor at STAT. He\u2019s a data journalist with a background in bioinformatics and molecular biology. You can reach Emory on Signal at jaspar.01.","email_address":"emory.parker@statnews.com","email_url":"mailto:emory.parker@statnews.com","twitter_url":"","twitter_handle":"","facebook_url":"","linkedin_url":"","web_url":"","bluesky_url":"https:\/\/bsky.app\/profile\/jaspar.bsky.social","bluesky_handle":"@jaspar.bsky.social"},{"avatar":"<img width=\"80\" height=\"80\" src=\"https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/mario-a-avatar-small-80x80.png\" class=\"avatar\" alt=\"Mario Aguilar\" loading=\"lazy\" sizes=\"auto, (max-width: 80px) 100vw, 80px\" decoding=\"async\" srcset=\"https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/mario-a-avatar-small-80x80.png 80w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/mario-a-avatar-small-328x328.png 328w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/mario-a-avatar-small-1024x1024.png 1024w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/mario-a-avatar-small-768x768.png 768w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/mario-a-avatar-small-500x500.png 500w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/mario-a-avatar-small-640x640.png 640w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/mario-a-avatar-small-576x576.png 576w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/mario-a-avatar-small-160x160.png 160w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/mario-a-avatar-small-645x645.png 645w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/mario-a-avatar-small.png 1200w\" \/>","display_name":"Mario Aguilar","author_page":"https:\/\/www.statnews.com\/staff\/mario-aguilar\/","first_name":"Mario","title":"Health Tech Correspondent","bio":"Mario Aguilar covers technology in health care, including artificial intelligence, virtual reality, wearable devices, telehealth, and digital therapeutics. His stories explore how tech is changing the practice of health care and the business and policy challenges to realizing tech's promise. He\u2019s also the co-author of the free, twice weekly <a href=\"https:\/\/www.statnews.com\/signup\/health-tech\/\">STAT Health Tech newsletter<\/a>. You can reach Mario on Signal at mariojoze.13.","email_address":"mario.aguilar@statnews.com","email_url":"mailto:mario.aguilar@statnews.com","twitter_url":"https:\/\/x.com\/mariojoze","twitter_handle":"@mariojoze","facebook_url":"","linkedin_url":"https:\/\/www.linkedin.com\/in\/mario-aguilar-13361235\/","web_url":"","bluesky_url":"","bluesky_handle":""}],"stat_card_curation":{"image_id":1144389,"title":"","excerpt":"","video_id":0,"disable_topic_image_curation":false},"template_inline_styles":[],"stat_byline_classes":["article-byline","multi-author"],"use_block_editor_for_post":false,"stat_featured_video":null,"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.5 (Yoast SEO v26.5) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Keep tabs on the FDA&#039;s &#039;startup&#039; program for medical devices<\/title>\n<meta name=\"description\" content=\"STAT identified hundreds of medical devices designated as &quot;breakthroughs&quot; by the FDA. Explore them by indication, manufacturer, and more.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.statnews.com\/feature\/stat-plus\/breakthrough-device-designation-fda-tracker\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"An authoritative database of FDA&#039;s fast-tracked medical devices\" \/>\n<meta property=\"og:description\" content=\"The FDA&#039;s Breakthrough Device program is growing rapidly, but remains secretive. So STAT built a comprehensive database searchable by indication, manufacturer, regulatory pathway, and more.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.statnews.com\/feature\/stat-plus\/breakthrough-device-designation-fda-tracker\/\" \/>\n<meta property=\"og:site_name\" content=\"STAT\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/statnews\/\" \/>\n<meta property=\"article:published_time\" content=\"2022-04-18T08:35:38+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-03-11T02:59:16+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.statnews.com\/wp-content\/uploads\/2022\/04\/Meta-Image-Breakthrough-Device-Tracker-1024x576.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1024\" \/>\n\t<meta property=\"og:image:height\" content=\"576\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Lizzy Lawrence, Katie Palmer, J. 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