Medtronic's Stealth AXiS™ Surgical System Receives FDA Clearance for Cranial and ENT Procedures
Medtronic has received FDA clearance for its Stealth AXiS™ surgical system for cranial and ENT procedures. This system, which previously received clearance for spine procedures, integrates surgical planning, navigation, and robotics. It features AI-enabled architecture and intraoperative ultrasound technology for enhanced precision and visualization. The system aims to improve surgical workflows and patient outcomes across multiple specialties.
Medtronic has obtained FDA clearance for its Stealth AXiS™ surgical system, which is now approved for cranial and ear, nose, and throat (ENT) procedures, following its earlier clearance for spine surgeries. The system combines surgical planning, navigation, and robotics into a unified platform, featuring AI-based automatic tractography for generating brain maps and intraoperative ultrasound integration through GE HealthCare's bkActiv technology. Designed to enhance surgical precision and efficiency, the system operates within Medtronic's AiBLE smart ecosystem, allowing for continuous software innovation and expanded capabilities across various clinical settings.
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