Intuitive, a global leader in minimally invasive care and a pioneer in robotic-assisted surgery, announced that the U.S. Food and Drug Administration (FDA) has cleared new software enhancements for its Ion endoluminal system (Ion).
Ion, Intuitive’s robotic-assisted bronchoscopy platform, utilizes an ultra-thin, shape-sensing catheter that can navigate deep into the lungs. This advanced system allows physicians to reach small, hard-to-access nodules and accurately position biopsy instruments to sample potentially cancerous tissue.
The latest software update introduces artificial intelligence throughout Ion’s navigational workflow and incorporates advanced imaging capabilities to enhance precision and efficiency in lung biopsy procedures.
Lung cancer remains the leading cause of cancer-related deaths globally and in the United States for more than 25 years. Research shows that early detection significantly improves the five-year survival rate, and accurate biopsy of difficult-to-reach nodules is a crucial step in effective lung cancer diagnosis and treatment.
“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
The latest AI-powered navigation upgrade for Ion builds on the system’s proven capabilities to address a major challenge in lung biopsy known as CT-to-body divergence—a situation where a lung nodule’s position changes between the pre-procedure CT scan and the actual procedure due to lung movement. This shift can make it harder to accurately reach the target and collect an effective biopsy sample.
With this update, Ion now leverages AI to make real-time corrections. By integrating computer vision with its shape-sensing technology, the system compares live images with the pre-planned route and dynamically adjusts navigation—much like a GPS recalculating directions when conditions change. These advancements are designed to enhance workflow efficiency, minimize manual adjustments, improve precision, and help physicians deliver faster, more confident diagnoses.
Expanded Advanced Imaging
Intuitive is also rolling out enhanced imaging capabilities, including integrated tomosynthesis, to expand access to advanced imaging. This feature allows real-time imaging updates using a standard 2D C-arm—offering a high-level imaging solution where options may be limited, and giving clinicians more flexibility to tailor biopsy workflows to each patient’s specific needs.
This comprehensive imaging suite underscores Intuitive’s commitment to supporting diverse healthcare settings and equipping physicians with cutting-edge tools to deliver accurate, efficient diagnostic outcomes.
These software upgrades will first be released through a limited launch to collect feedback across various clinical and operational environments, with a broader U.S. rollout 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, more than 900 Ion systems have been installed in hospitals across 10 countries.4 The growing body of clinical evidence now includes over 100 abstracts and publications highlighting the potential benefits of Ion technology for patients.5
Intuitive continues to sponsor and support an expanding portfolio of clinical studies using the Ion endoluminal system, including observational research involving more than 2,000 participants across Europe and the United States. These studies reflect the company’s dedication to building a strong global evidence base across diverse populations—driving research, guiding innovation, and supporting improved patient outcomes worldwide.
Please note that certain features may not be available in all countries. Product availability depends on regulatory approvals in each specific market. For more details, contact your local Intuitive representative.