StoryRegulatory
FDA clears Ion, Intuitive's robotic catheter system for minimally invasive lung biopsy
The FDA cleared Ion, Intuitive's robotic catheter system for biopsies deep in the lung on February 19, 2019. The 3.5 mm articulating catheter bends 180 degrees in any direction through narrow airways to reach small nodules, with a fiber-optic shape sensor tracking its position. Customer shipments began Q2 2019.
- Ultra-thin 3.5 mm articulating catheter bends 180 degrees in all directions through small, tortuous airways
- Fiber-optic shape sensor provides precise location and shape information during navigation and biopsy
- 2 mm working channel accommodates flexible biopsy needle, forceps or cytology brushes for tissue collection
- Shipments to U.S. customers began Q2 2019 in a measured introduction