Stealth AXiS™ Surgical System
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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 reports strong third quarter fiscal 2026 results with highest enterprise revenue growth in 10 quarters
Prnewswire· 2026-02-17 11:45
Core Insights - Medtronic reported strong financial results for Q3 FY26, achieving the highest enterprise revenue growth in 10 quarters, with total revenue of $9.017 billion, an increase of 8.7% year-over-year and 6.0% on an organic basis [1][2][3] Financial Performance - Q3 revenue by segment included: - Diabetes business revenue of $796 million, up 14.8% as reported and 8.3% organic - Medical Surgical Portfolio revenue of $2.173 billion, up 4.9% as reported and 2.7% organic - Neuroscience Portfolio revenue of $2.558 billion, up 4.1% reported and 2.5% organic - Cardiovascular Portfolio revenue of $3.457 billion, up 13.8% as reported and 10.6% organic [1][2][3] - GAAP diluted EPS was $0.89, while non-GAAP diluted EPS was $1.36, exceeding Q3 guidance by three cents [1][3] - The company reiterated its FY26 organic revenue growth guidance of approximately 5.5% and diluted non-GAAP EPS guidance of $5.62 to $5.66 [1][2] Strategic Developments - Medtronic executed two key M&A transactions in the quarter: acquiring CathWorks in Coronary and Renal Denervation and Anteris in Structural Heart [1][2] - The company secured U.S. FDA clearance for the Stealth AXiS™ Surgical System for spinal procedures and the Hugo™ robotic-assisted surgery system, with the first cases completed in February 2026 [1][2] - Cardiac Ablation Solutions revenue surged by 80%, including a remarkable 137% growth in the U.S., driven by the strength of the pulsed field ablation (PFA) portfolio [1][2] Market Position - Medtronic's innovation pipeline and portfolio breadth are highlighted as key factors for sustaining long-term growth, with the company expressing confidence in its ability to unlock new markets and invest in high-growth opportunities [1][2]