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

SUNNYVALE, Calif., Oct. 08, 2025 (GLOBE NEWSWIRE) -- Intuitive (NASDAQ:ISRG), a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, today announced that the U.S. Food & Drug Administration (FDA) has cleared software advancements for the Ion endoluminal system (Ion).

Ion, Intuitive’s robotic-assisted bronchoscopy platform, features an ultra-thin, shape-sensing catheter designed to navigate deep into the lung. This advanced technology enables physicians to access small, hard-to-reach nodules and precisely position biopsy tools to sample potentially cancerous tissue.

This latest software release introduces artificial intelligence across Ion’s entire navigational workflow, while also integrating new advanced imaging capabilities to support accurate and efficient lung biopsies.

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.

“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.