{"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":"fda-forschung-zur-apple-watch-bei-vorhofflimmern","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/fda-apple-watch-afib-research\/","title":{"rendered":"FDA qualifiziert die Vorhofflimmer-Verlaufsfunktion der Apple Watch als neues\u2026"},"content":{"rendered":"<p>Am 1. Mai 2024 machte die FDA eine bedeutende Ank\u00fcndigung, indem sie die <strong>Apple Watch AFib History-Funktion<\/strong> als Biomarker-Testger\u00e4t \u00fcber sein Medical Devices Development Tools (MDDT)-Programm.<\/p>\n<p>Die nun von der FDA zugelassene AFib-Verlaufsfunktion ist eine rezeptfreie, mobile medizinische Softwareanwendung f\u00fcr Benutzer ab 22 Jahren mit der Diagnose Vorhofflimmern (AFib). Diese innovative Funktion zielt darauf ab:<\/p>\n<p>\u2013 Hilfe zum besseren Verst\u00e4ndnis der Vorhofflimmern-Belastung bei Patienten<\/p>\n<p>\u2013 Bereitstellung erg\u00e4nzender Daten zu klinisch besser definierten Endpunkten<\/p>\n<p><strong>Auswirkungen f\u00fcr Patienten und Gesundheitsdienstleister:<\/strong><\/p>\n<ul>\n<li><strong>Verbesserte Patienten\u00fcberwachung<\/strong>: Die Vorhofflimmern-Verlaufsfunktion der Apple Watch hilft Patienten und medizinischem Personal, die Belastung durch Vorhofflimmern besser zu \u00fcberwachen und zu verstehen.<\/li>\n<li><strong>Erg\u00e4nzende klinische Daten<\/strong>: Die Funktion liefert wertvolle Daten, die traditionelle klinische Endpunkte erg\u00e4nzen und m\u00f6glicherweise die Ergebnisse der Patienten und Behandlungsstrategien verbessern.<\/li>\n<\/ul>\n<p><strong>N\u00e4chste Schritte f\u00fcr Sponsoren von Medizinprodukten:<\/strong><\/p>\n<p>Sponsoren von Medizinprodukten k\u00f6nnen jetzt die Funktion zur Vorhofflimmern-Historie in ihre Zulassungsantr\u00e4ge aufnehmen, indem sie im Anschreiben oder im Deckblatt 3514 des FDA CDRH Premarket Review Submission Cover Sheet auf die qualifizierte MDDT-Antragsnummer verweisen.<\/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>Lesen Sie den vollst\u00e4ndigen Artikel<\/span>\n\t<\/a>\n\n<p>\u00a9Dieser RegAlert wird herausgegeben von RegASK<\/p>","protected":false},"excerpt":{"rendered":"<p>Am 1. Mai 2024 gab die FDA eine wichtige Ank\u00fcndigung bekannt, indem sie die Vorhofflimmer-Verlaufsfunktion der Apple Watch im Rahmen ihres Programms f\u00fcr medizinische Ger\u00e4teentwicklungswerkzeuge (MDDT) als Biomarker-Testger\u00e4t qualifizierte. Die nun von der FDA zugelassene Vorhofflimmer-Verlaufsfunktion ist eine rezeptfreie, mobile medizinische Software-App, die f\u00fcr Nutzer ab 22 Jahren bestimmt ist.<\/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":[459,457,455,439,437,299,271,193],"class_list":["post-5174","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-devices-insights","tag-innovation-health","tag-otc","tag-clinical-data","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 v28.0 (Yoast SEO v28.3) - 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. 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