{"id":60722,"date":"2025-02-03T16:02:42","date_gmt":"2025-02-03T15:02:42","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/rapidai-secures-fda-510k-clearance-for-groundbreaking-ai-3d-head-and-neck-cta-imaging-lumina-3d\/"},"modified":"2025-02-03T16:02:42","modified_gmt":"2025-02-03T15:02:42","slug":"rapidai-secures-fda-510k-clearance-for-groundbreaking-ai-3d-head-and-neck-cta-imaging-lumina-3d","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/rapidai-secures-fda-510k-clearance-for-groundbreaking-ai-3d-head-and-neck-cta-imaging-lumina-3d\/","title":{"rendered":"RapidAI Secures FDA 510(k) Clearance for Groundbreaking AI 3D Head and Neck CTA Imaging: Lumina 3D\u2122"},"content":{"rendered":"
\n

\nRapidAI continues to pioneer AI advances by revolutionizing 3D imaging with no-click, AI-powered reconstruction<\/i><\/p>\n

SAN MATEO, Calif.–(BUSINESS WIRE)–RapidAI<\/a>, the global leader in AI-driven medical imaging analysis and coordinated care, has received FDA 510(k) clearance for Lumina 3D\u2122 by RapidAI\u2014an industry-first, automated 3D imaging reconstruction solution designed to replace manual workflows with an AI-powered approach based on the latest groundbreaking AI technology advances.<\/p>\n

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\n\u201cObtaining high-quality 3D images within minutes of a CTA scan marks a significant advancement and milestone in neuroradiology,\u201d stated Vivek Yedavalli, M.D., chief of neuroradiology at Johns Hopkins School of Medicine. \u201cWhen radiologists require a detailed view of the vasculature for an accurate diagnosis, challenges related to quality, availability, time, and cost present major obstacles. As Head and Neck CTA volumes increase, we continue to face a shortage of CT technicians and neuroradiologists. Lumina 3D\u2122 addresses these issues by providing near real-time, crystal-clear 3D views, vessel segmentation, and bone removal. This technology can assist in detecting anomalies, dissections, and stenosis more swiftly and accurately, potentially improving patient outcomes, significantly enhancing neuroradiologists\u2019 workflows, and supporting the radiology community.\u201d<\/p>\n

\nManual CTA reconstructions take considerable time, even with available resources, and turnaround times may stretch to hours, which can delay critical diagnoses and significantly hinder radiologists and neuro-interventionalists. Lumina 3D accomplishes this in minutes and runs in real-time. It is designed for large-scale applications, ensuring 24\/7 availability for hospitals of all sizes. Engineered for speed, accuracy, and efficiency, Lumina 3D alleviates the workload for imaging technologists and radiologists, boosts productivity, and can accelerate diagnosis and treatment processes, ultimately enhancing patient care and hospital throughput.<\/p>\n

\n\u201cHaving immediate access to high-quality 3D images of vascular structures marks a significant advancement in neuro-interventional surgery. Previously, navigating challenging anatomy required a process of trial and error. Lumina 3D changes the paradigm by removing the guesswork with near-instantaneous visualization of complex anatomy. With a 98% DICE score and results available in minutes, Lumina 3D’s level of automation, speed, and accuracy is unprecedented. We are entering an era of precise procedural planning where initial device selection is optimized for individual patient anatomy. Joining the best-in-class RAPID suite of products, this is a technology that delivers not just better imaging, but potentially better outcomes,\u201d said Daniel Gibson, M.D., neuro-interventionalist, Goodman Campbell Brain & Spine, Ascension Health (Indianapolis, USA).<\/p>\n

\nAs part of the Rapid Enterprise\u2122 Platform, Lumina 3D seamlessly integrates into existing workflows, providing reconstructions to clinicians throughout the hospital network. Neuro-interventional specialists can directly visualize compressed images of the aortic arch, carotid tortuosity, and entire neurovasculature on mobile devices. This enables faster and more accurate access planning and catheter selection, thereby reducing procedure times and enhancing first-pass reperfusion rates. Lumina 3D is exclusively deployed on Rapid Edge Cloud, the only engine in the industry that offers hospitals the flexibility of on-premises, cloud, or hybrid infrastructure. This ensures unmatched speed, security, and scalability\u2014a significant advantage for healthcare institutions optimizing AI-driven imaging solutions.<\/p>\n

\n\u201cAt RapidAI, our brand promise extends beyond just providing AI solutions\u2014we are dedicated partners in navigating the evolving complexities of clinical decision-making and care coordination for radiologists and interventionalists,\u201d said Karim Karti, chief executive officer at RapidAI. \u201cBy delivering the most advanced deep clinical AI-driven insights for imaging support, improving workflow efficiency, and providing measurable ROI for hospital service line programs, we empower clinicians to make faster, more confident decisions. Lumina 3D builds upon our deep clinical expertise in neuroscience, redefining AI-powered 3D imaging and paving the way for the next generation of advanced AI imaging and clinical decision-making technology.\u201d<\/p>\n

\nAbout RapidAI<\/b><\/p>\n

\nRapidAI is the world leader in AI-driven medical imaging analysis and coordinated care. With the industry\u2019s most validated clinical AI platform, we empower care teams to rapidly, precisely, and confidently manage life-threatening conditions. Trusted by thousands of hospitals in 100+ countries, RapidAI delivers the deepest level of clinical decision support on the market to help accelerate the time to treatment and enhance patient outcomes. We go beyond the algorithm to drive care team collaboration and efficiencies that expand access to life-saving interventions. At RapidAI, we establish new standards for care teams and the patients they treat.<\/p>\n

Contacts<\/b> <\/p>\n

\nRapidAI Media Contact:<\/b>
Jessica Stebing
\n
Group Manager, Marketing Communications
\n
260.336.6202
\n
stebing@rapidai.com<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

RapidAI continues to pioneer AI advances by revolutionizing 3D imaging with no-click, AI-powered reconstruction SAN MATEO, Calif.–(BUSINESS WIRE)–RapidAI, the global leader in AI-driven medical imaging analysis and coordinated care, has received FDA 510(k) clearance for Lumina 3D\u2122 by RapidAI\u2014an industry-first, automated 3D imaging reconstruction solution designed to replace manual workflows with an AI-powered approach based … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-60722","6":"format-standard","7":"category-industry"},"yoast_head":"\nRapidAI Secures FDA 510(k) Clearance for Groundbreaking AI 3D Head and Neck CTA Imaging: Lumina 3D\u2122 - Pharma Trend<\/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:\/\/pharma-trend.com\/en\/rapidai-secures-fda-510k-clearance-for-groundbreaking-ai-3d-head-and-neck-cta-imaging-lumina-3d\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"RapidAI Secures FDA 510(k) Clearance for Groundbreaking AI 3D Head and Neck CTA Imaging: Lumina 3D\u2122 - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"RapidAI continues to pioneer AI advances by revolutionizing 3D imaging with no-click, AI-powered reconstruction SAN MATEO, Calif.–(BUSINESS WIRE)–RapidAI, the global leader in AI-driven medical imaging analysis and coordinated care, has received FDA 510(k) clearance for Lumina 3D\u2122 by RapidAI\u2014an industry-first, automated 3D imaging reconstruction solution designed to replace manual workflows with an AI-powered approach based ... 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