Intuitive Surgical (Nasdaq: ISRG) announced today that it received CE mark for its da Vinci 5 surgical robotic system.
The surgical robotics leader earned approval for adult and pediatric use in Europe. da Vinci 5 works across minimally invasive endoscopic procedures in the abdominopelvic space. That includes urologic, gynecologic and general laparoscopic surgical procedures, plus thoracoscopic procedures.
da Vinci 5, Intuitive’s latest-generation robot, won FDA clearance last year, further cementing its place atop the surgical robotic space. The company began its commercial rollout in the U.S. this year. Features include new surgeon controllers and powerful vibration and tremor controls. The company calls da Vinci 5 its smoothest and most precise system to date.
(For more on the wide world of surgical robotics, see our special report on the space.)
Intuitive says da Vinci 5 features more than 150 enhancements. The Force Feedback-enabled technology accompanies realistic 3D vision and an ergonomic, immersive surgeon console. Intuitive says it offers greater operational efficiency and actionable insights as well.
“We are pleased that our da Vinci 5 Surgical System has received CE mark approval, marking its entry to Europe,” said Intuitive CEO Dave Rosa. “At Intuitive, we’re focused on providing healthcare systems across Europe and around the world with thoughtful innovation that solves problems today and into the future. After over a decade of careful development, da Vinci 5 is the most advanced and integrated platform we’ve ever created – designed to enable better outcomes, efficiency, and insights for the future of minimally invasive care.”
CE mark represents the latest recent regulatory milestone for Intuitive. In May, the company won FDA clearance for a new indication for its da Vinci single port (SP) surgical robot. Clearance extended da Vinci SP’s capabilities in colorectal surgery.
