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Medtronic Receives FDA Clearance for Stealth AXiS™ Surgical System for Cranial and ENT Procedures
Prnewswire· 2026-03-27 13:00
Core Insights - Medtronic has received FDA clearance for the Stealth AXiS™ surgical system, which integrates surgical planning, navigation, and robotics for cranial and ENT procedures, enhancing precision and real-time insights for surgeons [1][2]. Group 1: Product Features and Capabilities - The Stealth AXiS™ system combines advanced navigation, robotics, and AI-enabled capabilities within the AiBLE™ smart ecosystem, providing deeper insights throughout the surgical workflow [2]. - The system features AI-based automatic tractography for cranial procedures, allowing surgeons to create patient-specific brain maps and visualize critical neural pathways [2]. - For ENT procedures, the system offers high-precision navigation and advanced visualization tailored to the complex anatomy of the sinuses and skull base, enhancing decision-making in the operating room [3][4]. Group 2: Market Position and Strategy - Medtronic's Cranial and Spinal Technologies business serves over 4 million patients annually with a portfolio of 150 products addressing more than 20 pathologies, emphasizing a patient-centric approach [6]. - The ENT business impacts nearly 3 million patients each year and has been a leader in surgical navigation for over 25 years, continuously advancing care through innovative technologies [7]. - The Stealth AXiS™ system is positioned as the next generation of navigation for ENT surgery, building on Medtronic's legacy of navigation leadership [5].
Medtronic receives FDA clearance for Stealth AXiS™ surgical system, first integrated planning, navigation and robotics platform for spine surgery
Prnewswire· 2026-02-13 13:00
Core Insights - Medtronic has received FDA clearance for the Stealth AXiS™ surgical system, which integrates planning, navigation, and robotics for spine surgery, marking a significant advancement in surgical technology [1] Company Overview - Medtronic is a global leader in healthcare technology, headquartered in Galway, Ireland, with over 95,000 employees across more than 150 countries [1] - The company aims to alleviate pain, restore health, and extend life through innovative technologies that address various health conditions [1] Product Details - The Stealth AXiS™ system is designed for spine procedures and has an architecture that supports future cranial and ENT applications, pending further FDA clearance [1] - This system combines familiar navigation workflows with a modular robotic design, allowing for flexibility in deployment according to clinical needs [1] Technological Innovations - A key feature of the Stealth AXiS™ system is LiveAlign™ segmental tracking, which provides real-time visualization of anatomic motion and surgical adjustments, reducing the need for repeated imaging [1] - The system is part of Medtronic's AiBLE™ smart ecosystem, facilitating a seamless flow of information across the surgical continuum [1] Market Position - Medtronic's Cranial and Spinal Technologies division serves over 4 million patients annually with a portfolio of 150 products addressing more than 20 pathologies [1] - The company focuses on building durable platforms that simplify surgical workflows while enabling future expansions across various procedures and specialties [1]