Thursday, July 31, 2025

Intuitive Surgical obtains CE mark for da Vinci 5 robotic


The da Vinci 5 system contains quite a few enhancements over the earlier mannequin. | Supply: Intuitive Surgical

Intuitive Surgical Inc. yesterday mentioned that its da Vinci 5 Surgical System has obtained CE mark approval for grownup and pediatric use in Europe. The robotic is allowed for minimally invasive endoscopic procedures throughout the abdominopelvic and thoracoscopic area, together with urologic, gynecologic, and common laparoscopic procedures.

“At Intuitive, we’re centered on offering healthcare techniques throughout Europe and world wide with considerate innovation that solves issues at this time and into the longer term,” said Dave Rosa, CEO of Intuitive Surgical. “After over a decade of cautious improvement, da Vinci 5 is essentially the most superior and built-in platform we’ve ever created – designed to allow higher outcomes, effectivity, and insights for the way forward for minimally invasive care.”

Sunnyvale, Calif.-based Intuitive Surgical is a world chief in minimally invasive care and robot-assisted surgical procedure. Its choices embrace the da Vinci surgical system and the Ion endoluminal system. The firm mentioned it combines superior techniques, progressive learnings, and value-enhancing companies to assist the very best affected person outcomes potential.

da Vinci 5 designed for important healthcare challenges

da Vinci 5 is Intuitive Surgical’s latest-generation robotic. The corporate has designed a number of fashions of the surgical system, which incorporates high-definition 3D imaginative and prescient, a magnified view, and robotic and pc help.

The robots use specialised instrumentation, together with a miniaturized surgical digicam and wristed devices equivalent to scissors, scalpels, and forceps. All are designed to assist with exact dissection and reconstruction deep contained in the human physique.

Intuitive mentioned that da Vinci 5 is its smoothest and most exact multiport system up to now. Its options greater than 150 enhancements, together with new surgeon controllers and vibration and tremor controls. The corporate mentioned it designed da Vinci 5 to ship:

  • Enhanced surgical senses to assist higher affected person outcomes, together with Drive Suggestions-enabled expertise, essentially the most practical 3D da Vinci imaginative and prescient system up to now, and an ergonomic, immersive surgeon console to assist surgeon profession longevity.
  • Operational effectivity, by way of larger surgeon autonomy with the combination of key elements that surgeons can management at their fingertips. The system may streamline workflows with an easy-to-learn system, a common person interface for care groups, and built-in dynamic help to automate choose duties, mentioned Intuitive.
  • Actionable insights by way of an clever platform with 10,000 instances extra computing energy and new sensors, software program, and superior processors. This supplies surgeons with extra usable information to assist them quantify, perceive, and enhance their surgical efficiency for sufferers.

“We consider that the operational efficiencies and actionable insights offered by da Vinci 5 is not going to solely assist rework surgical procedure but in addition assist handle important challenges confronted by healthcare techniques throughout Europe,” mentioned Dirk Barten, senior vice chairman and common supervisor for Europe at Intuitive.

Intuitive continues getting clearances

The U.S. Meals and Drug Administration (FDA) final yr granted Intuitive Surgical clearance for da Vinci 5, and the corporate started its industrial rollout within the U.S. this yr.

Surgeons have used da Vinci techniques in additional than 410,000 procedures in Europe final yr and almost 17 million procedures up to now, mentioned Intuitive. The corporate has been growing techniques for 30 years, and its mentioned almost 90,000 surgeons have been skilled on its techniques.

CE mark represents the newest regulatory milestone for Intuitive. In Could, it obtained FDA clearance for a brand new indication for its da Vinci single-port (SP) surgical robotic. Clearance prolonged da Vinci SP’s capabilities in colorectal surgical procedure.

In June, surgeons used a da Vinci Xi system to carry out what they claimed was the primary robotic heart-transplant process within the U.S.

Additionally final month, Restore Robotics introduced the first-in-human use of a remanufactured da Vinci Xi robotic instrument. The corporate holds the one clearance from the FDA to remanufacture these devices, which it makes out there to hospitals by way of Encore Medical System Restore, its industrial companion. It led to a downgrade of Intuitive by Deutsche Financial institution, however BofA remained bullish.

“It’s thrilling that surgeons and care groups throughout Europe can have their selection of the total portfolio of da Vinci techniques, together with da Vinci 5, giving them larger selection and adaptability, and finally supporting high quality look after extra sufferers throughout the area,” mentioned Barten.

Editor’s be aware: This text was syndicated from The Robotic Report sibling web site MassDevice



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