Intuitive Surgical wins FDA clearance for robotic-assisted lung biopsy system

Intuitive Surgical’s Ion system includes an articulating robotic catheter able to navigate through small and tortuous airways during lung biopsy procedures. [Image courtesy of Intuitive Surgical]

Intuitive Surgical (NSDQ:ISRG) said today that FDA has cleared its Ion system — a robotic-assisted, catheter-based platform meant to enable minimally invasive biopsy deep within the lung.

Sunnyvale, Calif.–based Intuitive plans to start selling the Ion system in the U.S. in a measured fashion; it’ll start shipping to customers in coming months.

The Ion system includes an articulating robotic catheter with an outer diameter of only 3.5 mm that is able to move 180 degrees in all directions, allowing a physician to navigate the catheter through small and tortuous airways to reach nodules. The system’s Flexision Biopsy Needle is also able to pass through tight bends as it travels through the Ion’s catheter to collect peripheral lung tissue. Other biopsy tools are also able to fit inside the catheter’s 2 mm working channel, including biopsy forceps or cytology brushes.

Fiber optic shape sensor technology in the Ion system provides the catheter’s precise location and shape information throughout the procedure. Intuitive officials say they designed the Ion system to easily integrate into existing lung nodule biopsy workflows.

“The Ion system represents Intuitive’s continued commitment to innovating for minimally invasive care, and extends our focus beyond surgery,” said Intuitive Surgical CEO Gary Guthart. “At Intuitive, we innovate for need, and lung cancer is clearly a global health challenge that requires new modalities of care.”

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