Intuitive Surgical wins FDA nod for daVinci X platform

Intuitive Surgical (NSDQ:ISRG) said today it won FDA 510(k) clearance for its new da Vinci X robotic surgical system, with a planned release of the platform later this year.

The newly cleared da Vinci X system offers access to multiple robotic-assisted surgical technologies at a lower price than previous models, the Sunnyvale, Calif.-based company said. The system operates on the same vision cart and surgeon consoles used by the company’s flagship da Vinci Xi system.

“This new system enables access to Intuitive’s leading and proven robotic-assisted surgical technology at a lower price point. 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,” CEO Dr. Gary Guthart said in a prepared statement.

Intuitive said that the da Vinci X system allows for focused-quadrant surgery and features flexible port placement and 3D digital optics, while also including advanced instruments and accessories from its Xi system.

“The da Vinci X System is a value-oriented option for hospitals that are just starting their robotic-assisted surgical program and for our existing customers who want to expand their existing robotics programs. As customers’ needs grow, the da Vinci X System can grow with them.  The da Vinci X System enables our customers to take immediate advantage of Intuitive’s full ecosystem of support and services,” US sales senior VP Henry Charlton said in a press release.

The da Vinci X system won CE Mark approval in the European Union in April. A month earlier, Intuitive Surgical saw shares rise after the robotic surgical platform maker posted 1st quarter earnings that beat expectations on the Street.

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