FDA expands clearance for Intuitive Surgical’s FireFly imaging system

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.

"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."

Intuitive Surgical’s share price lost 25.3% this year as the company struggled with a series of studies finding robotic surgery equally safe and effective but more expensive than laparoscopy. Investors, who sent ISRG shares to an all-time high of $585.82 apiece in April 2012, have carved some 36.6% from the stock since then. ISRG shares were going for $371.33 each as of about 10:15 a.m. today, down 0.9%.

Prices tumbled 11.1% in a single day last February, to $509.33 per share, after a report in the Journal of the American Medical Assn. also questioned the value of hysterectomies using robotic surgery. In March, the president of the American College of Obstetricians & Gynecologists, Dr. James Breeden,criticized robotic surgery hysterectomies.

A study published earlier this month found that robotic surgeries may be under-reported and therefore less safe than they appear, a conclusion Intuitive called "misleading." Studies published last year raised similar concerns regarding robotic surgery prostatectomies and robotic surgeries to treat endometrial cancer.

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