FDA expands clearance for Intuitive Surgical's FireFly imaging system

September 23, 2013 by Brad Perriello

The FDA expands the 510(k) clearance for Intuitive Surgical's FireFly imaging system in gallbladder procedures.

FDA clears Intuitive Surgical's FireFly imaging system

Intuitive Surgical (NSDQ:ISRG) said the FDA expanded the 510(k) clearance for its FireFly fluorescence imaging system to use during gallbladder surgery using its da Vinci robotic surgery device.

The device uses a video camera and fluorescent dye to show blood flow in vessels and tissue, by causing blood to appear green and bloodless tissue as gray, according to a press release.

The expanded clearance adds real-time imaging of the cystic, common bile and common ducts, according to the release. Sunnyvale, Calif.-based Intuitive said the device is designed to help surgeons distinguish between the common bile duct and the cystic duct.

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"As a surgeon, real time and precise images during surgery are enormously helpful in achieving good patient outcomes," chief medical advisor Dr. Myriam Curet said in prepared remarks. "Intuitive Surgical has been committed to surgical innovation for more than a decade, providing surgeons with not only improved surgical dexterity, but enhanced visualization during surgery. We will continue to innovate and enhance the da Vinci Surgical System to provide surgeons with tools that help deliver optimal patient outcomes."

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