FDA clears Ion software that adds AI across navigation and integrates new imaging; 900+ systems installed

Intuitive Surgical/Ion

The FDA cleared new Ion software using AI throughout navigation, including real-time correction for lung nodules shifting from pre-procedure CT. Tomosynthesis 3D imaging from standard 2D X-ray arms was added. Over 900 Ion systems installed in 10 countries; broader US rollout planned for 2026.

• AI navigation corrects for CT-to-body divergence: nodules shift position during procedure due to lung motion.
• Tomosynthesis integrates 3D reconstruction from standard C-arm, expanding access where CT isn't available.
• 900+ systems installed globally; >200,000 procedures completed as of June 2025; proof of market adoption.
• 2026 broader US rollout expected; imaging and AI upgrades reinforce Ion competitive position vs bronchoscopy.