FDA Clears Stealth AXiS Surgical System for Robotic Spine Surgery (MDTX)

The U.S. Food and Drug Administration cleared Medtronic's (MDTX) Stealth AXiS Surgical System for robotic spine surgery, effective February 13, 2026. This marks the first CE marking for a robotic system in the spine segment, expanding the company's reach in minimally invasive surgical robotics. The approval is based on clinical data showing improved accuracy and reduced operating time for specific procedures. The system is indicated for thoracic and lumbar interbody fusion and for the placement of spinal instrumentation. Medtronic expects the clearance to drive growth in its surgical robotics segment, potentially boosting revenue and market share in the $1.5B robotic surgery market.