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Home » Intuitive Surgical expands into transoral surgery with new FDA win

Intuitive Surgical expands into transoral surgery with new FDA win

September 18, 2014 By Arezu Sarvestani

Intuitive Surgical wins new FDA clearance for da Vinci systems

Intuitive Surgical (NSDQ:ISRG) is looking to widen its reach in transoral surgery with FDA clearance to market the older da Vinci S and Si systems in benign, base of tongue resection procedures.

The devices were previously cleared for transoral otolaryngology, but the FDA indication was limited to resection of early stage tumors. The new FDA clearance doesn’t apply to Intuitive’s next-generation da Vinci Xi model.

"I am pleased with this next step in our progress in serving the transoral otolaryngology market," chief scientific officer and executive vice president Dave Rose said in prepared remarks. "The significance of this clearance is ENT physicians can now offer their patients a new minimally invasive option for benign base of tongue resection procedures."

The news did little for Intuitive’s shares, which gained 0.3% today and were trading at $475.16 as of about 12:35 p.m. EST. The stock has gained 23.7% since the start of the year.

The device maker recently touted another FDA win for its Firefly blood and tissue imaging technology. Firefly allows surgeons to swap between standard lighting and near-infrared imaging combined with injectable fluorescent dye that makes it easier to see blood flow.

Filed Under: News Well, Otolaryngology/Ear, Nose & Throat (ENT), Regulatory/Compliance, Surgical Robotics Tagged With: Intuitive Surgical

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