{"id":855,"date":"2025-12-03T17:48:05","date_gmt":"2025-12-03T17:48:05","guid":{"rendered":"https:\/\/mlhealth360.com\/?page_id=855"},"modified":"2025-12-04T04:55:06","modified_gmt":"2025-12-04T04:55:06","slug":"fda-cleared-announcement","status":"publish","type":"page","link":"https:\/\/mlhealth360.com\/?page_id=855","title":{"rendered":"FDA Cleared Announcement"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"855\" class=\"elementor elementor-855\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-93b5cf4 e-flex e-con-boxed e-con e-parent\" data-id=\"93b5cf4\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-608a668 e-con-full e-flex e-con e-child\" data-id=\"608a668\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-42b2196 elementor-widget elementor-widget-heading\" data-id=\"42b2196\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">Scaida<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e14a058 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"e14a058\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">BrainCT-ICH:\u2028Now FDA Cleared<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7e4a67b elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"7e4a67b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\tCanada\u2019s First FDA-Cleared AI for Intracranial Hemorrhage Triage. Our AI-powered detection delivers unparalleled accuracy and reliability with an average processing time of just 5.97 seconds. \t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-894c882 e-con-full e-flex e-con e-child\" data-id=\"894c882\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0111376 elementor-widget elementor-widget-button\" data-id=\"0111376\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#contactfrom\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Request A Demo<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-59ec64c e-con-full elementor-hidden-mobile e-flex e-con e-child\" data-id=\"59ec64c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a67829f elementor-widget elementor-widget-spacer\" data-id=\"a67829f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-9a36848 e-flex e-con-boxed e-con e-parent\" data-id=\"9a36848\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8f9cda3 elementor-widget__width-inherit elementor-widget elementor-widget-heading\" data-id=\"8f9cda3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">mlHealth 360 Receives FDA Clearance for Scaida BrainCT-ICH: Canada\u2019s First AI Solution for Intracranial Hemorrhage Triage<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-aa6efc6 elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"aa6efc6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li style=\"font-weight: 400;\" aria-level=\"1\"><b>Major Regulatory Milestone:<\/b><span style=\"font-weight: 400;\"> The first Canadian-developed AI for ICH triage receives FDA clearance to enter the U.S. market.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><b>Operational Value:<\/b><span style=\"font-weight: 400;\"> Automates prioritization of critical cases to alleviate radiologist burnout.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><b>Workflow Efficiency:<\/b><span> High Specificity (0.887) minimizes false alarms; average processing time of 5.97 seconds.<\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1f401b1 elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"1f401b1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><b>SURREY, British Columbia \u2014 December 3, 2025<\/b><span style=\"font-weight: 400;\"> \u2014 <\/span><b>mlHealth 360<\/b><span style=\"font-weight: 400;\"> today announced that the U.S. Food and Drug Administration (FDA) has granted <\/span><b>510(k) clearance (K250694)<\/b><span style=\"font-weight: 400;\"> for <\/span><b>Scaida BrainCT-ICH<\/b><span style=\"font-weight: 400;\">, an AI-powered triage solution designed to address critical bottlenecks in acute care radiology.<\/span><\/p><p><span style=\"font-weight: 400;\">This clearance establishes Scaida BrainCT-ICH as the first Canadian-developed AI solution for intracranial hemorrhage (ICH) triage to be cleared for clinical use in the United States.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-98da372 elementor-widget elementor-widget-heading\" data-id=\"98da372\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">Addressing the Volume Crisis in Radiology\n<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-712b46b elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"712b46b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Radiology departments worldwide are experiencing unprecedented imaging demand. As volumes grow, radiologists face increasing cognitive load and burnout, and emergency studies risk sitting unreviewed in a backlog during the very moments when minutes matter most.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c959810 elementor-widget elementor-widget-heading\" data-id=\"c959810\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">The Solution: Automated Prioritization\n<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4f8ee90 elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"4f8ee90\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Built on the clinical principle that <\/span><b>&#8220;Time is Brain,&#8221;<\/b><span style=\"font-weight: 400;\"> Scaida BrainCT-ICH cuts through the noise to support overburdened teams. Functioning as an <\/span><b>always-on sentry<\/b><span style=\"font-weight: 400;\">, the system automatically analyzes non-contrast head CT scans immediately after acquisition.<\/span><\/p><p><span style=\"font-weight: 400;\">When the AI identifies a suspected hemorrhage, it alerts the care team and moves the study to the top of the radiologist\u2019s worklist. This ensures that life-threatening findings are reviewed first, rather than sitting in a queue due to high volume.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-daf7dbb elementor-widget elementor-widget-heading\" data-id=\"daf7dbb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">Impact for Healthcare Operations\n<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-561c278 elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"561c278\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>For hospital systems, Scaida BrainCT-ICH delivers immediate ROI by optimizing existing resources.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a4bf6df elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"a4bf6df\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>&#8220;We engineered this tool to be a force multiplier for radiologists, not a distraction,&#8221; said <b>Mahesh Shankar<\/b>, Director, Advanced Analytics &amp; Innovation at mlHealth 360.\u00a0&#8220;With a <b>specificity of 0.887<\/b>, the system is designed to minimize false positives. This combats &#8216;alert fatigue&#8217; and ensures that radiologists can trust the notifications they receive.&#8221;<\/p><p><strong>Key operational benefits include:<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3742d9c elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"3742d9c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li style=\"font-weight: 400;\" aria-level=\"1\"><b>Speed:<\/b><span style=\"font-weight: 400;\"> Average processing time of <\/span><b>5.97 seconds<\/b><span style=\"font-weight: 400;\">, ensuring no workflow delays.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><b>Integration:<\/b><span style=\"font-weight: 400;\"> Seamlessly integrates with existing <\/span><b>PACS and RIS<\/b><span style=\"font-weight: 400;\"> environments. <\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><b>Resource Allocation:<\/b><span> Reduces time-to-read for high-acuity cases during peak ER hours.<\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8d5f57c elementor-widget elementor-widget-heading\" data-id=\"8d5f57c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">From Regulatory Milestone to Global Scale\n<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b85324b elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"b85324b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">\u201cThis FDA clearance is an important validation of our approach to building a scalable intelligence layer for modern radiology,\u201d said <\/span><b>Kumar Surender Sinwar<\/b><span style=\"font-weight: 400;\">, Founder &amp; CEO of mlHealth 360.<\/span><\/p><p><span style=\"font-weight: 400;\">\u201cICH triage represents one of the most time-sensitive challenges in acute care. With this foundation in place, we are developing expanded capabilities across chest, abdominal, and whole-body imaging to support health systems worldwide.\u201d<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cc52e2c elementor-widget elementor-widget-heading\" data-id=\"cc52e2c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">Validated Performance<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-006953f elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"006953f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">The FDA clearance is supported by rigorous validation across six U.S. institutions, covering multiple scanner manufacturers (GE, Toshiba, Siemens) and diverse patient populations.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c02a581 elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"c02a581\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li>Specificity: 0.887<\/li><li>Sensitivity: 0.867<\/li><li>Area Under the Curve (AUC): 0.926<\/li><li>Average Processing Time: 5.97 seconds<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3116908 elementor-widget elementor-widget-heading\" data-id=\"3116908\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">Regulatory Intended Use\n<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a24d629 elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"a24d629\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Scaida BrainCT-ICH is intended to assist trained radiologists in workflow triage by flagging suspected intracranial hemorrhages. The device does not alter original medical images and is not intended for primary diagnostic interpretation.\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-948f594 elementor-widget elementor-widget-heading\" data-id=\"948f594\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">About mlHealth 360\n<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c29f2c4 elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"c29f2c4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">mlHealth 360 is a global healthtech company transforming radiology with secure, cloud-native AI solutions. Our medical imaging platforms improve reporting speed and healthcare efficiency while integrating seamlessly into existing hospital infrastructure.\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9c5f3ec elementor-widget elementor-widget-heading\" data-id=\"9c5f3ec\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">Media &amp; Demo Inquiries\n<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0937841 elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"0937841\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">For demo requests or to explore evaluation opportunities, please contact mlHealth 360.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">Mahesh Shankar<\/span><\/p><p><span style=\"font-weight: 400;\">Director, Advanced Analytics &amp; Innovation, mlHealth 360<\/span><span style=\"font-weight: 400;\"><br \/><\/span><span style=\"color: #ffffff;\"><a style=\"color: #ffffff;\" href=\"mailto:mahesh@mlhealth360.com\"><span style=\"font-weight: 400;\">mahesh@mlhealth360.com<\/span><span style=\"font-weight: 400;\"><br \/><\/span><\/a><a style=\"color: #ffffff;\" href=\"https:\/\/mlhealth360.com\/\"><span style=\"font-weight: 400;\">https:\/\/mlhealth360.com\/<\/span><\/a><\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Scaida BrainCT-ICH:\u2028Now FDA Cleared Canada\u2019s First FDA-Cleared AI for Intracranial Hemorrhage Triage. Our AI-powered detection delivers unparalleled accuracy and reliability with an average processing time of just 5.97 seconds. Request A Demo mlHealth 360 Receives FDA Clearance for Scaida BrainCT-ICH: Canada\u2019s First AI Solution for Intracranial Hemorrhage Triage Major Regulatory Milestone: The first Canadian-developed AI [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-855","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/mlhealth360.com\/index.php?rest_route=\/wp\/v2\/pages\/855","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mlhealth360.com\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/mlhealth360.com\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/mlhealth360.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/mlhealth360.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=855"}],"version-history":[{"count":34,"href":"https:\/\/mlhealth360.com\/index.php?rest_route=\/wp\/v2\/pages\/855\/revisions"}],"predecessor-version":[{"id":956,"href":"https:\/\/mlhealth360.com\/index.php?rest_route=\/wp\/v2\/pages\/855\/revisions\/956"}],"wp:attachment":[{"href":"https:\/\/mlhealth360.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=855"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}