Intuitive Expands AI and Advanced Imaging Integration in Ion Endoluminal System

FDA-cleared software release enhances navigation and broadens access to advanced imaging for lung biopsy procedures 

Intuitive, a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, announced that the U.S. Food & Drug Administration (FDA) has cleared software advancements for the Ion endoluminal system (Ion).

Lung cancer has been the leading cause of cancer-related deaths both globally and in the U.S. for over 25 years, with studies showing early diagnosis of lung cancer is associated with a higher five-year survival rate.^1,2,3 A key step in lung cancer management is diagnosis, which often requires a biopsy of complex nodules in challenging locations within the lung.

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“These latest Ion software advancements reflect Intuitive’s ongoing commitment to advancing lung cancer care through meaningful innovation,” said Intuitive Chief Executive Officer 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-powered enhanced navigation
Ion’s latest AI-powered enhanced navigation builds on its existing strengths to address a key challenge in lung biopsy known as CT-to-body divergence—when a lung nodule is in a different location during the procedure relative to the pre-procedure CT scan due to movement of the lung. This shift can make it more difficult to reach the target accurately and perform an effective biopsy.

Ion will now use AI to help correct this in real time. By combining computer vision with Ion’s shape-sensing technology, the system compares live images to the original plan and adjusts the view along the navigation path as needed—similar to a GPS that reroutes when conditions change. These enhancements are designed to increase workflow efficiency, reduce manual steps, improve accuracy, and could give physicians greater confidence in delivering answers to patients quickly.

Expanding advanced imaging
Intuitive is introducing new and improved advanced imaging capabilities, including integrated tomosynthesis—to broaden access to advanced imaging. This innovation enables real-time imaging updates with a standard 2D C-arm, offering an advanced imaging option where alternatives are limited and providing physicians with multiple options to tailor biopsy workflows to each patient’s clinical need.

This diverse offering reflects Intuitive’s commitment to supporting a wide range of healthcare environments and providing physicians with the advanced imaging tools they need to find answers for patients—accurately and efficiently.

These software features will initially be introduced through a limited launch to gather insights into performance across a range of clinical and operational environments. A broader launch in the U.S. is planned for 2026.

“We know that early diagnosis can make a life-changing difference for patients with lung cancer,” said Federico Barbagli, PhD, Senior Vice President and General Manager, 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.”

Ion’s global footprint
As of June 30, 2025, there were more than 900 Ion systems in place in hospitals across 10 countries.⁴ In addition, the body of evidence continues to grow with more than 100 abstracts and publications describing the potential value delivered to patients.⁵

Intuitive is actively sponsoring and supporting a growing portfolio of clinical studies using the Ion endoluminal system, including observational research involving more than 2,000 subjects across the EU and U.S. These studies underscore the company’s commitment to generating global evidence across diverse populations—advancing research, informing innovation, and supporting improved patient outcomes worldwide.

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