Intuitive has received U.S. Food and Drug Administration (FDA) clearance for software enhancements to its Ion endoluminal system.

Ion is the company’s robotic-assisted bronchoscopy platform. It features an ultra-thin, shape-sensing catheter designed to navigate deep into the lung. The technology allows physicians to reach small, hard-to-reach nodules and precisely position biopsy tools to sample potentially cancerous tissue.

This software release introduces artificial intelligence (AI) to Ion’s entire navigational workflow. It also integrates new advanced imaging capabilities to support accurate, 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-powered navigation

Ion’s new AI-powered navigation aims to address CT-to-body divergence—when a lung nodule is in a different spot during the procedure relative to the pre-procedure scan because of lung movement. This can make it harder to accurately reach the target and perform an effective biopsy.

Ion can now use AI to help correct this in real time. It combines computer vision with Ion’s shape-sensing tech to compare live images to the original plan and adjust the view along the navigation path as needed. The enhancements hope to grow workflow efficiency, reduce manual steps, and improve accuracy.

Advanced imaging

Integrated tomosynthesis is being integrated to broaden access to advanced imaging. This allows real-time imaging updates with a standard 2D C-arm, providing an advanced imaging option where alternatives are limited.

It also offers physicians multiple options to tailor biopsy workflows to each patient’s clinical need, Intuitive said.

The new software features will first be introduced though limited launch to gain insights into performance in a range of clinical and operational settings. Broader U.S. launch is planned for 2026.

“We know that early diagnosis can make a life-changing difference for patients with lung cancer,” said Federico Barbagli, Ph.D., senior VP 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.”

Last month, the company debuted he first in a series of new software capabilities for the da Vinci 5 robotic surgery system that offer real-time surgical insights.