da Vinci 5 Surgical System approved in Europe

The da Vinci 5 Surgical System has received CE Mark approval in Europe for use across minimally invasive abdominopelvic and thoracoscopic surgical procedures, including urologic, gynecologic, and general laparoscopic procedures in adult and pediatric patients, Intuitive announced in a news release.¹

The da Vinci 5 platform was approved in the US in March 2024.

The da Vinci 5 platform was previously granted 510(k) clearance by the FDA in March 2024 for use in urologic, general, gynecologic, and thoracic procedures in adult patients.² Featuring more than 150 enhancements, the system represents the most advanced platform within Intuitive’s portfolio of multiport robotic-assisted surgical systems, which also includes the da Vinci Xi and X systems. Intuitive also offers a single-port platform, the da Vinci SP.

“We are pleased that our da Vinci 5 Surgical System has received CE mark approval, marking its entry to Europe,” said David J. Rosa, CEO of Intuitive, in the news release.¹ “At Intuitive, we’re focused on providing health care 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.”

According to the company, the da Vinci 5 platform includes features to enhance surgical performance, such as Force Feedback enabled technology and an ergonomic, immersive surgeon console.

In a prior news release, the company noted, “In preclinical trials with surgeons at all experience levels, Force Feedback demonstrated up to 43 percent less force exerted on tissue, which may translate to less trauma on tissue.”²

The system is also designed to promote operational efficiency with the integration of key OR technologies such as insufflation and an electrosurgical unit. The optimized user interface also includes settings that are “accessible by the broader surgical team and by the surgeon directly from the head-in menu,” Intuitive reported.²

Further, the fifth edition of the surgical console includes new surgeon controllers, vibration and tremor controls, and Intuitive’s highest quality and most natural 3D imaging system to date.

“We believe that the operational efficiencies and actionable insights provided by da Vinci 5 will not only help transform surgery but also help address critical challenges faced by health care systems across Europe,” added Dirk Barten, Intuitive senior vice president and general manager for Europe, in the news release.¹ “It's exciting that surgeons and care teams across Europe will have their choice of the full portfolio of da Vinci systems, including da Vinci 5, giving them greater choice and flexibility, and ultimately supporting quality care for more patients across the region.”

REFERENCES

1. Intuitive’s da Vinci 5 Surgical System Receives CE Mark. News release. Intuitive Surgical, Inc. Published online and accessed July 2, 2025. https://isrg.intuitive.com/news-releases/news-release-details/intuitives-da-vinci-5-surgical-system-receives-ce-mark

2. Intuitive announces FDA clearance of fifth-generation robotic system, da Vinci 5. News release. Intuitive. March 14, 2024. Accessed July 2, 2025. https://isrg.intuitive.com/news-releases/news-release-details/intuitive-announces-fda-clearance-fifth-generation-robotic