{"id":5174,"date":"2024-06-11T14:01:28","date_gmt":"2024-06-11T06:01:28","guid":{"rendered":"https:\/\/regask.com\/?p=5174"},"modified":"2024-11-05T20:56:54","modified_gmt":"2024-11-05T12:56:54","slug":"recherche-sur-la-fibrillation-auriculaire-de-la-fda-pour-apple-watch","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/fda-apple-watch-afib-research\/","title":{"rendered":"La FDA qualifie la fonction d&#039;historique de la fibrillation auriculaire de l&#039;Apple Watch comme une nouvelle fonctionnalit\u00e9"},"content":{"rendered":"<p>Le 1er mai 2024, la FDA a fait une annonce importante en qualifiant le <strong>Historique de la fibrillation auriculaire sur Apple Watch<\/strong> en tant que dispositif de test de biomarqueurs gr\u00e2ce \u00e0 son programme d&#039;outils de d\u00e9veloppement de dispositifs m\u00e9dicaux (MDDT).<\/p>\n<p>La fonctionnalit\u00e9 d&#039;historique de la fibrillation auriculaire (FA), d\u00e9sormais autoris\u00e9e par la FDA, est une application m\u00e9dicale mobile en vente libre, exclusivement logicielle, destin\u00e9e aux utilisateurs \u00e2g\u00e9s de 22 ans et plus ayant re\u00e7u un diagnostic de fibrillation auriculaire (FA). Cette fonctionnalit\u00e9 innovante vise \u00e0 :<\/p>\n<p>\u2013 Aider \u00e0 mieux comprendre le fardeau de la FA chez les patients<\/p>\n<p>\u2013 Fournir des donn\u00e9es suppl\u00e9mentaires pour des crit\u00e8res d\u2019\u00e9valuation cliniquement mieux d\u00e9finis<\/p>\n<p><strong>Impact pour les patients et les prestataires de soins de sant\u00e9 :<\/strong><\/p>\n<ul>\n<li><strong>Surveillance am\u00e9lior\u00e9e des patients<\/strong>:La fonction d\u2019historique de la FA sur l\u2019Apple Watch aide les patients et les prestataires de soins de sant\u00e9 \u00e0 mieux surveiller et comprendre le fardeau de la FA.<\/li>\n<li><strong>Donn\u00e9es cliniques suppl\u00e9mentaires<\/strong>:Cette fonctionnalit\u00e9 fournit des donn\u00e9es pr\u00e9cieuses qui compl\u00e8tent les crit\u00e8res cliniques traditionnels, am\u00e9liorant potentiellement les r\u00e9sultats des patients et les strat\u00e9gies de traitement.<\/li>\n<\/ul>\n<p><strong>Prochaines \u00e9tapes pour les promoteurs de dispositifs m\u00e9dicaux :<\/strong><\/p>\n<p>Les sponsors de dispositifs m\u00e9dicaux peuvent d\u00e9sormais inclure la fonctionnalit\u00e9 d&#039;historique de la FA dans leurs soumissions r\u00e9glementaires en r\u00e9f\u00e9ren\u00e7ant le num\u00e9ro de soumission MDDT qualifi\u00e9 dans la lettre d&#039;accompagnement ou dans le formulaire 3514 de la feuille de couverture de soumission d&#039;examen pr\u00e9alable \u00e0 la mise sur le march\u00e9 de la FDA CDRH.<\/p>\n<p>&nbsp;<\/p>\n<a data-animate=\"fadeInLeft\" href=\"https:\/\/www.fda.gov\/medical-devices\/medical-device-development-tools-mddt\" target=\"_blank\" class=\"button secondary is-link is-medium\" rel=\"noopener\" >\n\t\t<span>Lire l&#039;article complet<\/span>\n\t<\/a>\n\n<p>\u00a9Cette RegAlert est \u00e9mise par RegASK<\/p>","protected":false},"excerpt":{"rendered":"<p>On May 1, 2024, the FDA made a significant announcement by qualifying the Apple Watch AFib History Feature as a biomarker test device through its Medical Devices Development Tools (MDDT) program. The AFib history feature, now cleared by the FDA, is a commercially available over-the-counter (OTC) software-only mobile medical application intended for users 22 years&#8230;<\/p>","protected":false},"author":39,"featured_media":4713,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[39],"tags":[455,459,457,439,437,299,271,193],"class_list":["post-5174","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-devices-insights","tag-clinical-data","tag-innovation-health","tag-otc","tag-mddt-submission","tag-apple-watch","tag-regulatory-intelligence","tag-clinical-trial","tag-fda"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v27.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA Approves Apple Watch for AFib Research | RegASK<\/title>\n<meta name=\"description\" content=\"The FDA has qualified the Apple Watch AFib History feature as a medical device development tool. Learn more with RegASK.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/fr\/recherche-sur-la-fibrillation-auriculaire-de-la-fda-pour-apple-watch\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Qualifies Apple Watch AFib History Feature as a New Medical Devices Development Tools\" \/>\n<meta property=\"og:description\" content=\"The FDA has qualified the Apple Watch AFib History feature as a medical device development tool. Learn more with RegASK.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/fr\/recherche-sur-la-fibrillation-auriculaire-de-la-fda-pour-apple-watch\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2024-06-11T06:01:28+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-05T12:56:54+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2024\/01\/fda-qualifies-apple-watch-afib-history-feature-new-medical-devices-development-tools.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1600\" \/>\n\t<meta property=\"og:image:height\" content=\"1200\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Benoit Trouwaert\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Benoit Trouwaert\" \/>\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:\\\/\\\/regask.com\\\/fda-apple-watch-afib-research\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-apple-watch-afib-research\\\/\"},\"author\":{\"name\":\"Benoit Trouwaert\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\"},\"headline\":\"FDA Qualifies Apple Watch AFib History Feature as a New&hellip;\",\"datePublished\":\"2024-06-11T06:01:28+00:00\",\"dateModified\":\"2024-11-05T12:56:54+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-apple-watch-afib-research\\\/\"},\"wordCount\":223,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-apple-watch-afib-research\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/01\\\/fda-qualifies-apple-watch-afib-history-feature-new-medical-devices-development-tools.png\",\"keywords\":[\"Clinical Data\",\"Innovation Health\",\"OTC\",\"MDDT Submission\",\"Apple Watch\",\"Regulatory Intelligence\",\"Clinical trial\",\"FDA\"],\"articleSection\":[\"Medical Devices\"],\"inLanguage\":\"fr-FR\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/fda-apple-watch-afib-research\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/fda-apple-watch-afib-research\\\/\",\"name\":\"FDA Approves Apple Watch for AFib Research | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-apple-watch-afib-research\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-apple-watch-afib-research\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/01\\\/fda-qualifies-apple-watch-afib-history-feature-new-medical-devices-development-tools.png\",\"datePublished\":\"2024-06-11T06:01:28+00:00\",\"dateModified\":\"2024-11-05T12:56:54+00:00\",\"description\":\"The FDA has qualified the Apple Watch AFib History feature as a medical device development tool. 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