{"id":94658,"date":"2024-05-02T17:41:17","date_gmt":"2024-05-02T17:41:17","guid":{"rendered":"https:\/\/entertainment.runfyers.com\/index.php\/2024\/05\/02\/fda-qualifies-apple-watchs-afib-history-for-use-in-clinical-studies\/"},"modified":"2024-05-02T17:41:17","modified_gmt":"2024-05-02T17:41:17","slug":"fda-qualifies-apple-watchs-afib-history-for-use-in-clinical-studies","status":"publish","type":"post","link":"https:\/\/entertainment.runfyers.com\/index.php\/2024\/05\/02\/fda-qualifies-apple-watchs-afib-history-for-use-in-clinical-studies\/","title":{"rendered":"FDA qualifies Apple Watch\u2019s AFib history for use in clinical studies"},"content":{"rendered":"<p> <br \/>\n<\/p>\n<div>\n<p class=\"duet--article--dangerously-set-cms-markup duet--article--standard-paragraph mb-20 font-fkroman text-18 leading-160 -tracking-1 selection:bg-franklin-20 dark:text-white dark:selection:bg-blurple [&amp;_a:hover]:shadow-highlight-franklin dark:[&amp;_a:hover]:shadow-highlight-blurple [&amp;_a]:shadow-underline-black dark:[&amp;_a]:shadow-underline-white\">The Apple Watch\u2019s atrial fibrillation (AFib) history feature, which records and alerts the wearer\u2019s relevant heart events, <a href=\"https:\/\/content.govdelivery.com\/accounts\/USFDA\/bulletins\/399d551\" target=\"_blank\" rel=\"noopener\">has been qualified to join<\/a> the FDA\u2019s Medical Device Development Tools (MDDT) program \u2014 a first for a \u201cdigital health technology.\u201d That means the Apple Watch is now usable in clinical studies that need estimated data on how much time the wearer spent in atrial fibrillation while wearing the device, <a href=\"https:\/\/9to5mac.com\/2024\/05\/02\/apple-watch-afib-feature-fda\/\" target=\"_blank\" rel=\"noopener\"><em>9to5Mac<\/em> reports<\/a>. <\/p>\n<\/div>\n<div>\n<p class=\"duet--article--dangerously-set-cms-markup duet--article--standard-paragraph mb-20 font-fkroman text-18 leading-160 -tracking-1 selection:bg-franklin-20 dark:text-white dark:selection:bg-blurple [&amp;_a:hover]:shadow-highlight-franklin dark:[&amp;_a:hover]:shadow-highlight-blurple [&amp;_a]:shadow-underline-black dark:[&amp;_a]:shadow-underline-white\">The FDA announcement describes using it as a noninvasive way to collect the data both before and after treatment:<\/p>\n<\/div>\n<div>\n<blockquote class=\"duet--article--blockquote jzbdts2\">\n<p class=\"duet--article--dangerously-set-cms-markup jzbdtsa jzbdts0\"><strong>Designed to be used as a biomarker test<\/strong>\u00a0to help evaluate estimates of AFib burden as a secondary effectiveness endpoint within clinical studies intended to evaluate the safety and effectiveness of cardiac ablation devices to treat.<\/p>\n<\/blockquote>\n<\/div>\n<div>\n<p class=\"duet--article--dangerously-set-cms-markup duet--article--standard-paragraph mb-20 font-fkroman text-18 leading-160 -tracking-1 selection:bg-franklin-20 dark:text-white dark:selection:bg-blurple [&amp;_a:hover]:shadow-highlight-franklin dark:[&amp;_a:hover]:shadow-highlight-blurple [&amp;_a]:shadow-underline-black dark:[&amp;_a]:shadow-underline-white\">Apple has long touted its watch as <a href=\"https:\/\/www.theverge.com\/2022\/9\/9\/23344306\/apple-watch-series-8-emergency-health-heart-monitor\" target=\"_blank\" rel=\"noopener\">a lifesaver<\/a> for those who wear one. Features such as fall detection and car crash detection have been credited with saving lives. Apple often cites Apple Watch customer anecdotes in its marketing who say they visited their doctors after receiving heart-related alerts on their wrists \u2014 which potentially saved their lives. However, <a href=\"https:\/\/www.theverge.com\/2021\/8\/19\/22630463\/smartwatch-health-anxiety-heart-alerts-patient-education\" target=\"_blank\" rel=\"noopener\">added anxiety from extra data<\/a> could also be detrimental.<\/p>\n<\/div>\n<div>\n<p class=\"duet--article--dangerously-set-cms-markup duet--article--standard-paragraph mb-20 font-fkroman text-18 leading-160 -tracking-1 selection:bg-franklin-20 dark:text-white dark:selection:bg-blurple [&amp;_a:hover]:shadow-highlight-franklin dark:[&amp;_a:hover]:shadow-highlight-blurple [&amp;_a]:shadow-underline-black dark:[&amp;_a]:shadow-underline-white\">The FDA previously <a href=\"https:\/\/www.theverge.com\/2018\/9\/13\/17855006\/apple-watch-series-4-ekg-fda-approved-vs-cleared-meaning-safe\" target=\"_blank\" rel=\"noopener\">granted clearance<\/a> to two Apple Watch functions as a direct-to-consumer wearable device with an electrocardiogram and to notify you if you have an irregular heartbeat, starting with the <a href=\"https:\/\/www.theverge.com\/2018\/9\/12\/17850660\/apple-watch-series-4-ekg-electrocardiogram-health-2018\" target=\"_blank\" rel=\"noopener\">Series 4 in 2018<\/a>. It also specified that the apps are \u201cnot intended to replace traditional methods of diagnosis or treatment\u201d \u2014 if you feel off or have questions, you should still rely on a real doctor. The Apple Watch doesn\u2019t diagnose conditions, and one study suggested treatments for the conditions <a href=\"https:\/\/www.theverge.com\/2022\/3\/2\/22958156\/apple-watch-heart-rhythm-detection-benefit\" target=\"_blank\" rel=\"noopener\">don\u2019t fit the typical Apple Watch user<\/a>.<\/p>\n<\/div>\n<p><br \/>\n<br \/><a href=\"https:\/\/www.theverge.com\/2024\/5\/2\/24147178\/fda-apple-watch-mddt-qualification-afib-history\" target=\"_blank\" rel=\"noopener\">Source link <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Apple Watch\u2019s atrial fibrillation (AFib) history feature, which records and alerts the wearer\u2019s relevant heart events, has been qualified to join the FDA\u2019s Medical Device Development Tools (MDDT) program \u2014 a first for a \u201cdigital health technology.\u201d That means the Apple Watch is now usable in clinical studies that need estimated data on how [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":94659,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[14],"tags":[],"class_list":{"0":"post-94658","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-tech"},"_links":{"self":[{"href":"https:\/\/entertainment.runfyers.com\/index.php\/wp-json\/wp\/v2\/posts\/94658","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/entertainment.runfyers.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/entertainment.runfyers.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/entertainment.runfyers.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/entertainment.runfyers.com\/index.php\/wp-json\/wp\/v2\/comments?post=94658"}],"version-history":[{"count":0,"href":"https:\/\/entertainment.runfyers.com\/index.php\/wp-json\/wp\/v2\/posts\/94658\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/entertainment.runfyers.com\/index.php\/wp-json\/wp\/v2\/media\/94659"}],"wp:attachment":[{"href":"https:\/\/entertainment.runfyers.com\/index.php\/wp-json\/wp\/v2\/media?parent=94658"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/entertainment.runfyers.com\/index.php\/wp-json\/wp\/v2\/categories?post=94658"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/entertainment.runfyers.com\/index.php\/wp-json\/wp\/v2\/tags?post=94658"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}