{"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-%e8%8b%b9%e6%9e%9c%e6%89%8b%e8%a1%a8%e5%bf%83%e6%88%bf%e9%a2%a4%e5%8a%a8%e7%a0%94%e7%a9%b6","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/fda-apple-watch-afib-research\/","title":{"rendered":"FDA \u5c06 Apple Watch AFib \u5386\u53f2\u8bb0\u5f55\u529f\u80fd\u8ba4\u5b9a\u4e3a\u65b0\u529f\u80fd\u2026\u2026"},"content":{"rendered":"<p>2024 \u5e74 5 \u6708 1 \u65e5\uff0cFDA \u53d1\u5e03\u4e86\u4e00\u9879\u91cd\u8981\u58f0\u660e\uff0c\u5c06 <strong>Apple Watch AFib \u5386\u53f2\u8bb0\u5f55\u529f\u80fd<\/strong> \u4f5c\u4e3a\u751f\u7269\u6807\u5fd7\u7269\u6d4b\u8bd5\u8bbe\u5907\uff0c\u901a\u8fc7\u5176\u533b\u7597\u5668\u68b0\u5f00\u53d1\u5de5\u5177\uff08MDDT\uff09\u8ba1\u5212\u3002<\/p>\n<p>AFib \u5386\u53f2\u8bb0\u5f55\u529f\u80fd\u73b0\u5df2\u83b7\u5f97 FDA \u6279\u51c6\uff0c\u662f\u4e00\u6b3e\u5e02\u552e\u7684\u975e\u5904\u65b9 (OTC) \u8f6f\u4ef6\u79fb\u52a8\u533b\u7597\u5e94\u7528\u7a0b\u5e8f\uff0c\u9762\u5411 22 \u5c81\u53ca\u4ee5\u4e0a\u60a3\u6709\u5fc3\u623f\u98a4\u52a8 (AFib) \u7684\u7528\u6237\u3002\u6b64\u521b\u65b0\u529f\u80fd\u65e8\u5728\uff1a<\/p>\n<p>\u2013 \u5e2e\u52a9\u66f4\u597d\u5730\u4e86\u89e3\u60a3\u8005\u7684 AFib \u8d1f\u62c5<\/p>\n<p>\u2013 \u4e3a\u4e34\u5e8a\u4e0a\u66f4\u660e\u786e\u7684\u7ec8\u70b9\u63d0\u4f9b\u8865\u5145\u6570\u636e<\/p>\n<p><strong>\u5bf9\u60a3\u8005\u548c\u533b\u7597\u670d\u52a1\u63d0\u4f9b\u8005\u7684\u5f71\u54cd\uff1a<\/strong><\/p>\n<ul>\n<li><strong>\u589e\u5f3a\u60a3\u8005\u76d1\u6d4b<\/strong>\uff1aApple Watch \u4e0a\u7684 AFib \u5386\u53f2\u8bb0\u5f55\u529f\u80fd\u53ef\u5e2e\u52a9\u60a3\u8005\u548c\u533b\u7597\u4fdd\u5065\u63d0\u4f9b\u8005\u66f4\u597d\u5730\u76d1\u6d4b\u548c\u4e86\u89e3 AFib \u7684\u8d1f\u62c5\u3002<\/li>\n<li><strong>\u8865\u5145\u4e34\u5e8a\u6570\u636e<\/strong>\uff1a\u8be5\u529f\u80fd\u63d0\u4f9b\u4e86\u8865\u5145\u4f20\u7edf\u4e34\u5e8a\u7ec8\u70b9\u7684\u5b9d\u8d35\u6570\u636e\uff0c\u6709\u53ef\u80fd\u6539\u5584\u60a3\u8005\u7684\u6cbb\u7597\u7ed3\u679c\u548c\u6cbb\u7597\u7b56\u7565\u3002<\/li>\n<\/ul>\n<p><strong>\u533b\u7597\u5668\u68b0\u8d5e\u52a9\u5546\u7684\u540e\u7eed\u6b65\u9aa4\uff1a<\/strong><\/p>\n<p>\u533b\u7597\u5668\u68b0\u8d5e\u52a9\u5546\u73b0\u5728\u53ef\u4ee5\u901a\u8fc7\u5728\u5c01\u9762\u4fe1\u6216 FDA CDRH \u4e0a\u5e02\u524d\u5ba1\u67e5\u63d0\u4ea4\u5c01\u9762\u8868 3514 \u4e2d\u5f15\u7528\u5408\u683c\u7684 MDDT \u63d0\u4ea4\u7f16\u53f7\uff0c\u5c06 AFib \u5386\u53f2\u8bb0\u5f55\u529f\u80fd\u7eb3\u5165\u5176\u76d1\u7ba1\u63d0\u4ea4\u4e2d\u3002<\/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>\u9605\u8bfb\u5168\u6587<\/span>\n\t<\/a>\n\n<p>\u00a9\u672c RegAlert \u7531 RegASK \u53d1\u5e03<\/p>","protected":false},"excerpt":{"rendered":"<p>2024\u5e745\u67081\u65e5\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u53d1\u5e03\u4e86\u4e00\u9879\u91cd\u8981\u516c\u544a\uff0c\u901a\u8fc7\u5176\u533b\u7597\u5668\u68b0\u5f00\u53d1\u5de5\u5177\uff08MDDT\uff09\u8ba1\u5212\uff0c\u5c06Apple Watch\u7684\u623f\u98a4\u5386\u53f2\u8bb0\u5f55\u529f\u80fd\u8ba4\u5b9a\u4e3a\u751f\u7269\u6807\u5fd7\u7269\u68c0\u6d4b\u8bbe\u5907\u3002\u8be5\u623f\u98a4\u5386\u53f2\u8bb0\u5f55\u529f\u80fd\u73b0\u5df2\u83b7\u5f97FDA\u6279\u51c6\uff0c\u662f\u4e00\u6b3e\u9762\u541122\u5c81\u53ca\u4ee5\u4e0a\u7528\u6237\u7684\u975e\u5904\u65b9\uff08OTC\uff09\u79fb\u52a8\u533b\u7597\u8f6f\u4ef6\u5e94\u7528\u7a0b\u5e8f\u3002<\/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. 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