Intuitive Surgical announces FDA clearance of da Vinci Single Port system

Intuitive announced that the U.S. Food and Drug Administration cleared the da Vinci Single Port surgical system for transanal local excision/resection, a form of minimally invasive surgery performed through a natural orifice to avoid abdominal surgical incisions for select procedures. This clearance extends the da Vinci SP’s capabilities in colorectal surgery, building upon procedures previously cleared by the FDA in November 2024, which include transabdominal procedures – low anterior resection, total mesorectal excision, colectomy, abdominoperineal resection, and sigmoidectomy. Intuitive engineered the da Vinci SP system to navigate in narrow body cavities requiring precise access, such as lower pelvis and rectal procedures. Its design and architecture support access to rectal anatomy by allowing surgeons to control up to three multi-jointed instruments and a high-definition articulating camera through a single entry point to work freely in the smaller space.