In Europe, the requirements of Regulation (EU) 2017\/745 for software products apply in particular. From a technical perspective, AI can be seen as a sub-discipline of software. According to Annex I No. 17 of the Regulation, software must be designed to ensure repeatability, reliability and performance in accordance with its intended use.<\/p>\n
The FDA, on the other hand, distinguishes between artificial intelligence and software-based medical devices. In addition, only “locked algorithms” that have a completed learning phase are currently permitted in the USA.<\/p>\n
While the FDA presented the Total Product Lifecycle (TPLC) concept in 2019, which is intended to enable AI-based medical software to continue learning, the question remains in the EU for the time being: How can artificial intelligence be used effectively and safely?<\/p>\n<\/div><\/div><\/div><\/div><\/div>
<\/i><\/div><\/div>Would you like to find out more about the approval of AI-based medical software?<\/p>\n<\/div>
Contact us now<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"author":5,"featured_media":3761,"template":"","categories":[78,45],"class_list":["post-3762","news","type-news","status-publish","has-post-thumbnail","hentry","category-ai","category-news-en"],"yoast_head":"\nApproval of AI-based medical software - BAYOOMED<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.bayoomed.com\/en\/news\/approval-of-ai-based-medical-software\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Approval of AI-based medical software\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.bayoomed.com\/en\/news\/approval-of-ai-based-medical-software\/\" \/>\n<meta property=\"og:site_name\" content=\"BAYOOMED\" \/>\n<meta property=\"article:modified_time\" content=\"2024-07-10T13:56:02+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.bayoomed.com\/wp-content\/uploads\/sites\/4\/2024\/06\/BAYOOMED-Zulassung-KI-basierter-medizinscher-Software.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2000\" \/>\n\t<meta property=\"og:image:height\" content=\"1333\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.bayoomed.com\\\/en\\\/news\\\/approval-of-ai-based-medical-software\\\/\",\"url\":\"https:\\\/\\\/www.bayoomed.com\\\/en\\\/news\\\/approval-of-ai-based-medical-software\\\/\",\"name\":\"Approval of AI-based medical software - 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