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Intuitive Surgical's Firefly Gets FDA Approval

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Intuitive Surgical, Inc. (ISRG - Free Report) revealed that its da Vinci Fluorescence Imaging Vision System, well known as Firefly, has received FDA 510(k) clearance for use in gallbladder surgery.

The clearance means surgeons would now be able to identify the biliary duct with the help of the Firefly Imaging system properly for laparoscopic gallbladder removal surgeries. While performing surgeries, there is a higher chance of mistakenly identifying the cystic duct as bile duct leading to injuries due to clipping and division of the common duct.

However, Firefly Fluorescence Imaging Vision System would help surgeons use a specialized video camera to view real-time imaging of bile ducts (cystic duct, common bile duct and common hepatic duct).

Further, it will be able to identify blood flowing in vessels and tissue during minimally invasive surgical procedures. While using the Firefly camera, tissue with blood appears green and the same without blood appears gray.

Intuitive Surgical launched Firefly in 2011 for use with the da Vinci Si Surgical System in the U.S. and Europe. The system combines a fluorescent dye with a specialized camera, endoscope and laser-based illuminator to allow surgeons to identify vasculature in three dimensions beneath tissue surfaces.

ISRG reported earnings per share of $3.90 in the second quarter of 2013, missing the Zacks Consensus Estimate of $4.05 per share but exceeded the year-ago level of $3.75 per share. The company reported revenues of $579 million for the second quarter, up 8% year over year and trailed the Zacks Consensus Estimate of $596 million.

Intuitive Surgical significantly lowered its 2013 guidance based on the company’s dismal performance. Due to soft capital sales of the da Vinci system, the company lowered its revenue expectation from flat to 7% for 2013. Previously, ISRG had provided its sales growth guidance in the range of 16% to 19% for 2013. Operating income is forecast in a band of 37% to 38% of sales (earlier 38% to 39%) for 2013.

Currently, ISRG retains a Zacks Rank #3 (Hold). Other stocks that are currently performing well in the medical instruments industry include Cynosure, Inc. , Delcath Systems, Inc. , and Echo Therapeutics, Inc. . All of them carry a Zacks Rank #2 (Buy).

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