Intuitive Surgical wins CE Mark for da Vinci X system

Intuitive Surgical (NSDQ:ISRG) said today it won CE Mark approval in the European Union for its new da Vinci X surgical system.

The da Vinci X system offers access to a portfolio of robotic-assisted surgical technologies at a price point lower 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.

“Over the past 21 years, Intuitive Surgical pioneered robotic-assisted surgery and we continue to lead the way in developing and bringing to market innovative technologies, outcomes-focused products and value-oriented solutions. Our surgeon, hospital and healthcare customers around the world told us that robotic-assisted surgery matters for their programs and their patients while underscoring the importance of providing choice from a clinical, technological and cost standpoint. The da Vinci X product offering provides a lower-cost solution to meet the needs of customers who want a choice in price points, while offering access to many of our recent innovations,” 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 was designed to expand access to the benefits that robotic-assisted surgery delivers to patients, surgeons and hospitals around the world, by providing a cost-conscious, high quality, highly capable solution. We are pleased to offer this new system in Europe, and look forward to doing so in the U.S. once we receive FDA clearance,” US sales senior VP Henry Charlton said in a press release.

Earlier this month, Intuitive Surgical saw shares rise after the robotic surgical platform maker posted 1st quarter earnings that beat expectations on the Street.

The company posted profits of $179.9 million, or $4.67 per share, on sales of $674 million for the 3 months ended March 31, equating to bottom-line growth of 31.8% while sales grew 13.4% compared with the same period in 2016.

After adjusting to exclude 1-time items, earnings per share were $5.09, a solid 14¢ above the consensus on Wall Street, where analysts were expecting to see sales of $666.5 million.

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