Intuitive earns expanded FDA nod for da Vinci single port system

Intuitive (NASDAQ: ISRG)+ announced today that it received FDA clearance for a new indication for its da Vinci single port (SP) surgical robot.

Sunnyvale, California–based Intuitive — the longtime leader in surgical robotics — received clearance for da Vinci SP for transanal local excision/resection. This form of minimally invasive surgery takes place through a natural orifice to avoid abdominal surgical incisions for select procedures.

Intuitive said the clearance extends da Vinci SP’s capabilities in colorectal surgery. It builds upon procedures previously cleared by the FDA in November 2024. Those included low anterior resection, total mesorectal excision, colectomy, abdominoperineal resection and sigmoidectomy.

The company designed da Vinci SP to navigate in narrow body cavities requiring precise access. This includes the lower pelvis and rectal procedures. The da Vinci SP’s design and architecture support access to rectal anatomy, Intuitive says. It allows surgeons to control up to three multi-jointed instruments and a high-definition articulating camera. They go through a single entry point to work freely in the smaller space.

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