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Intuitive Surgical Declines on Warning Letter From FDA

Intuitive Surgical Inc.’s sales trajectory may have hit a wall amid regulatory scrutiny over adverse events during operations using its surgical robots and concerns on whether the $1.5 million devices are cost effective.

The company’s revenue since 2006 has increased at least 20 percent each year to about $2.18 billion in 2012 while its stock price jumped fivefold. Then in February, Bloomberg News reported that U.S. regulators were surveying surgeons on the robots following a rise in reports that included as many as 70 deaths since 2009. A review of Food and Drug Administration records now shows reports of injuries involving robot procedures doubled in the first six months of 2013 compared with a year earlier.