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FDA clears new da Vinci X Surgical System

Intuitive Surgical’s new da Vinci X Surgical System has received FDA clearance in the United States. The da Vinci X System will provide surgeons and hospitals with access to some of the most advanced robotic-assisted surgery technology at a lower cost. FDA clearance of the da Vinci X System follows CE Mark, which was announced in April.

The launch of the da Vinci X System underscores Intuitive’s commitment to meeting customers’ needs with a strong value-oriented portfolio and an array of financing options.

“This new system enables access to Intuitive’s leading and proven robotic-assisted surgical technology at a lower price point,” said Dr. Gary Guthart, CEO of Intuitive Surgical. “Customers around the globe have different needs from a clinical, cost and technology perspective; Intuitive’s goal is to meet those needs by providing a range of products and solutions: the da Vinci X System helps us continue to do so.”

The da Vinci X System offers surgeons and hospitals access to Intuitive’s portfolio of advanced, innovative robotic-assisted surgical technologies – and its full ecosystem of programs, support, services, and solutions – at a lower price. The system uses the same vision cart and surgeon console that are found on its flagship product, the da Vinci Xi System, enabling customers the option of adding advanced capabilities, and providing a pathway for upgrading.

The da Vinci X System enables optimized, focused-quadrant surgery including procedures like prostatectomy, partial nephrectomy, benign hysterectomy and sacrocolpopexy, among others. The system features flexible port placement and 3D digital optics, while incorporating the same instruments and accessories as Intuitive’s flagship system. The new system drives operational efficiencies through set-up technology that uses voice and laser guidance, drape design that simplifies surgery prep, and a lightweight, fully integrated endoscope.

The da Vinci X System will be available for sale in the U.S. this year.

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