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The single-port surgical robotics system was OK'ed for use in inguinal hernia repair, cholecystectomy, and appendectomy procedures.
December 11, 2025
By: Sam Brusco
Associate Editor
Intuitive has received U.S. Food and Drug Administration (FDA) clearance of its da Vinci Single Port (SP) surgical system for use in inguinal hernia repair, cholecystectomy, and appendectomy procedures.
The FDA nods expand da Vinci SP’s capabilities and build on its existing U.S. clearances in urology, colorectal, thoracic, and transoral procedures.
“Da Vinci SP was designed to give surgeons advanced capability through a single port, offering the precision and control needed in narrow or deep anatomical spaces,” said Iman Jeddi, Ph.D., senior VP and GM, da Vinci Platforms and Product Operations at Intuitive. “This clearance is one part of our innovation pathway for SP. We continue to evolve the platform with new tools and capabilities that help teams pursue less invasive approaches and expand what’s possible with da Vinci SP.”
The system lets surgeons perform surgeries through a single incision or natural orifice for enhanced visualization and precision. Its design can access anatomy by allowing surgeons control of up to three multi-jointed instruments and an articulating 3D-HD endoscope through one entry point.
Over 500 peer-reviewed publications support da Vinci SP’s safety, efficacy, and outcomes, according to the company. SP is also approved for use in Europe, Japan, and Korea for a variety of procedures spanning multiple surgical disciplines.
“Advancing da Vinci SP is part of our long-term commitment to helping improve the future of patient care—supporting approaches that are less invasive, reduce recovery time, lower the total cost of care, and create a better experience for patients as they return to their lives,” said Myriam Curet, MD, executive VP and chief medical officer at Intuitive. “As we continue to innovate across our platforms, we remain focused on helping more patients access the benefits of minimally invasive care.”
In October, the company earned FDA clearance for software enhancements to its Ion endoluminal system. The software release introduces artificial intelligence (AI) to Ion’s entire navigational workflow. It also integrates new advanced imaging capabilities to support accurate, efficient lung biopsies.
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