The U.S. FDA cleared Medtronic’s Hugo robotic‑assisted surgery (RAS) system, a regulatory milestone that gives the device maker a direct platform to challenge Intuitive Surgical’s da Vinci dominance in soft‑tissue robotic procedures. Medtronic plans to leverage global sales channels and service infrastructure to scale adoption. Industry analysts view the clearance as a meaningful competitive shift: the soft‑tissue robotics market is growing and multivendor competition could pressure pricing, procurement, and hospital adoption dynamics. Medtronic must still execute on training, outcomes data generation, and hospital economics to displace entrenched players. Robotic‑assisted surgery platforms integrate imaging, instruments and software to enhance surgeon precision; regulatory clearance enables commercial launch but further clinical and cost evidence will drive uptake.