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Intuitive Surgical’s da Vinci 5 wins European CE mark for advanced robotic surgery

July 3, 2025

Intuitive Surgical has achieved a significant milestone with its da Vinci 5 system now cleared with the CE mark for use across Europe. This approval means that both adult and paediatric procedures can benefit from this advanced tool, designed to streamline minimally invasive operations in areas such as the abdominopelvic region, urology, gynaecology, and general laparoscopic and thoracoscopic surgeries.

Following its FDA clearance last year, the da Vinci 5 is also making its commercial debut in the United States. With a host of innovations – like enhanced surgeon controls and refined vibration and tremor management – this system aims to make procedures smoother and more precise than ever. Intuitive describes it as their most precise and integrated platform to date.

The system incorporates over 150 improvements, including Force Feedback technology, realistic 3D vision, and an ergonomic surgeon console. These enhancements are crafted to boost operational efficiency and offer actionable insights, which is especially useful if you’ve ever wrestled with the challenges of traditional minimally invasive techniques.

Intuitive CEO Dave Rosa commented, “We are pleased that our da Vinci 5 Surgical System has received CE mark approval, marking its entry to Europe. 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.”

This European clearance adds to a trail of regulatory successes for the company, which recently expanded the capabilities of its da Vinci single port (SP) system for colorectal surgery, following new FDA clearance in May.

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