{"id":220324,"date":"2025-08-18T07:03:45","date_gmt":"2025-08-18T12:03:45","guid":{"rendered":"https:\/\/lifeboat.com\/blog\/2025\/08\/fda-okays-ai-based-prostate-cancer-risk-stratification-tool"},"modified":"2025-08-18T07:03:45","modified_gmt":"2025-08-18T12:03:45","slug":"fda-okays-ai-based-prostate-cancer-risk-stratification-tool","status":"publish","type":"post","link":"https:\/\/lifeboat.com\/blog\/2025\/08\/fda-okays-ai-based-prostate-cancer-risk-stratification-tool","title":{"rendered":"FDA Okays AI-Based Prostate Cancer Risk-Stratification Tool"},"content":{"rendered":"<p><a class=\"aligncenter blog-photo\" href=\"https:\/\/lifeboat.com\/blog.images\/fda-okays-ai-based-prostate-cancer-risk-stratification-tool.jpg\"><\/a><\/p>\n<p>The US FDA has granted De Novo marketing authorization for ArteraAI Prostate (Artera, Los Altos, California), a novel artificial intelligence (AI)-powered risk-stratification tool for patients with nonmetastatic prostate cancer.<\/p>\n<p>The authorization means the digital pathology software tool is recognized as an FDA-regulated Software as a Medical Device, Artera explained in a press release.<\/p>\n<p>De Novo authorization provides a marketing pathway to classify low-or moderate-risk novel medical devices. The De Novo authorization for this specific test establishes a new product code category for future AI-powered digital pathology risk-stratification tools and enables implementation at the point of diagnosis at qualified US pathology labs, the company said.<\/p>\n<p>The test analyzes digital pathology images from patients\u2019 biopsy slides to predict long-term outcomes, such as 10-year risk for metastasis and mortality. This can help direct treatment decisions.<\/p>\n<hr>\n<p>The FDA\u2019s De Novo authorization for the tool establishes a new product code category for future AI-powered digital pathology risk-stratification tools.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The US FDA has granted De Novo marketing authorization for ArteraAI Prostate (Artera, Los Altos, California), a novel artificial intelligence (AI)-powered risk-stratification tool for patients with nonmetastatic prostate cancer. The authorization means the digital pathology software tool is recognized as an FDA-regulated Software as a Medical Device, Artera explained in a press release. De Novo [\u2026]<\/p>\n","protected":false},"author":534,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[11,6],"tags":[],"class_list":["post-220324","post","type-post","status-publish","format-standard","hentry","category-biotech-medical","category-robotics-ai"],"_links":{"self":[{"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/posts\/220324","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/users\/534"}],"replies":[{"embeddable":true,"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/comments?post=220324"}],"version-history":[{"count":0,"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/posts\/220324\/revisions"}],"wp:attachment":[{"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/media?parent=220324"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/categories?post=220324"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/tags?post=220324"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}