{"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":"investigacion-sobre-la-fibrilacion-auricular-en-el-apple-watch-de-la-fda","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/fda-apple-watch-afib-research\/","title":{"rendered":"La FDA califica la funci\u00f3n de historial de fibrilaci\u00f3n auricular del Apple Watch como una nueva\u2026"},"content":{"rendered":"<p>El 1 de mayo de 2024, la FDA hizo un anuncio importante al calificar la <strong>Funci\u00f3n de historial de fibrilaci\u00f3n auricular del Apple Watch<\/strong> como dispositivo de prueba de biomarcadores a trav\u00e9s de su programa de Herramientas de Desarrollo de Dispositivos M\u00e9dicos (MDDT).<\/p>\n<p>La funci\u00f3n de historial de fibrilaci\u00f3n auricular, ahora aprobada por la FDA, es una aplicaci\u00f3n m\u00e9dica m\u00f3vil de venta libre (OTC) disponible comercialmente destinada a usuarios de 22 a\u00f1os o m\u00e1s que tengan un diagn\u00f3stico de fibrilaci\u00f3n auricular (FA). Esta innovadora funci\u00f3n tiene como objetivo:<\/p>\n<p>\u2013 Ayudar a comprender mejor la carga de fibrilaci\u00f3n auricular en los pacientes<\/p>\n<p>\u2013 Proporcionar datos complementarios a puntos finales mejor definidos cl\u00ednicamente<\/p>\n<p><strong>Impacto para los pacientes y los proveedores de atenci\u00f3n m\u00e9dica:<\/strong><\/p>\n<ul>\n<li><strong>Monitoreo mejorado del paciente<\/strong>:La funci\u00f3n de historial de fibrilaci\u00f3n auricular del Apple Watch ayuda a los pacientes y a los proveedores de atenci\u00f3n m\u00e9dica a controlar y comprender mejor la carga de la fibrilaci\u00f3n auricular.<\/li>\n<li><strong>Datos cl\u00ednicos complementarios<\/strong>:Esta funci\u00f3n proporciona datos valiosos que complementan los criterios de valoraci\u00f3n cl\u00ednicos tradicionales, mejorando potencialmente los resultados de los pacientes y las estrategias de tratamiento.<\/li>\n<\/ul>\n<p><strong>Pr\u00f3ximos pasos para los patrocinadores de dispositivos m\u00e9dicos:<\/strong><\/p>\n<p>Los patrocinadores de dispositivos m\u00e9dicos ahora pueden incluir la funci\u00f3n de historial de fibrilaci\u00f3n auricular en sus presentaciones reglamentarias haciendo referencia al n\u00famero de presentaci\u00f3n MDDT calificado en la carta de presentaci\u00f3n o en el formulario 3514 de la hoja de presentaci\u00f3n de revisi\u00f3n previa a la comercializaci\u00f3n del CDRH de la FDA.<\/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>Lea el art\u00edculo completo<\/span>\n\t<\/a>\n\n<p>\u00a9Esta alerta de registro es emitida por 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":[193,271,299,437,439,455,457,459],"class_list":["post-5174","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-devices-insights","tag-fda","tag-clinical-trial","tag-regulatory-intelligence","tag-apple-watch","tag-mddt-submission","tag-clinical-data","tag-otc","tag-innovation-health"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.0) - 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\/es\/investigacion-sobre-la-fibrilacion-auricular-en-el-apple-watch-de-la-fda\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\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\/es\/investigacion-sobre-la-fibrilacion-auricular-en-el-apple-watch-de-la-fda\/\" \/>\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 minutos\" \/>\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\":[\"FDA\",\"Clinical trial\",\"Regulatory Intelligence\",\"Apple Watch\",\"MDDT Submission\",\"Clinical Data\",\"OTC\",\"Innovation Health\"],\"articleSection\":[\"Medical Devices\"],\"inLanguage\":\"es\"},{\"@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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