Intuitive Surgical announced that it has received FDA clearance for new software advancements for its Ion endoluminal robotic bronchoscopy system.
The Ion system, initially FDA-cleared in 2019, is a robotic-assisted, catheter-based platform designed to perform minimally invasive biopsies deep within the lung. Its fiber optic shape-sensing technology provides precise location and shape information along the catheter’s length throughout procedures.
Ion’s ultra-thin, shape-sensing catheter navigates deep into the lungs to access small, hard-to-reach nodules, enabling physicians to accurately position biopsy tools and sample potentially cancerous tissue.
The latest software update introduces artificial intelligence across Ion’s entire navigational workflow and integrates advanced imaging capabilities, supporting more accurate and efficient lung biopsies.
“These latest Ion software advancements reflect Intuitive’s ongoing commitment to advancing lung cancer care through meaningful innovation,” said Intuitive CEO Dave Rosa. “By further integrating artificial intelligence with expanded advanced imaging capabilities, we’re equipping physicians with smarter tools designed to support early diagnosis and improve access to advanced care for more patients.”
AI Enhancements for Improved Lung Biopsy Accuracy
Sunnyvale, California-based Intuitive highlights that Ion’s AI-powered navigation addresses CT-to-body divergence, a common challenge when lung movement causes nodules to shift from their pre-procedure CT scan location. Ion now corrects this in real time, combining computer vision with shape-sensing technology to adjust navigation dynamically. This update improves workflow efficiency, reduces manual steps, and enhances accuracy, boosting physician confidence.
Intuitive also introduced improved advanced imaging features, including integrated tomosynthesis, which provides real-time imaging updates using a standard 2D C-arm, enabling workflows tailored to each patient’s needs.
The company plans a limited rollout of the new features to gather performance insights, with a broader launch expected in 2026.
“We know that early diagnosis can make a life-changing difference for patients with lung cancer,” said Federico Barbagli, SVP and GM, Endoluminal at Intuitive. “That’s why we continue to relentlessly innovate—advancing Ion’s capabilities to support more efficient, accurate, and personalized procedures across a wide range of healthcare environments. We’re committed to equipping care teams with the tools they need to deliver timely answers for patients and improve outcomes where it matters most.”
As of June 30, 2025, more than 900 Ion systems are installed in hospitals across 10 countries, with Intuitive continuing to expand the platform through these latest enhancements.
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