SUNNYVALE, Calif. — October 8, 2025 — Leads & Copy — Intuitive (NASDAQ:ISRG) announced FDA clearance for software advancements for its Ion endoluminal system, featuring AI and advanced imaging to improve lung biopsies.
The updated software integrates AI across Ion’s navigational workflow and adds new imaging capabilities, enhancing the robotic-assisted bronchoscopy platform’s ability to access small, hard-to-reach nodules. Ion uses an ultra-thin, shape-sensing catheter to precisely position biopsy tools for sampling potentially cancerous tissue, aiding in earlier and more accurate diagnoses.
Intuitive CEO Dave Rosa said the advancements reflect the company’s commitment to advancing lung cancer care through innovation. The AI-powered navigation corrects CT-to-body divergence in real time, using computer vision to adjust the navigation path. New integrated tomosynthesis broadens access to real-time imaging updates using a standard 2D C-arm, providing multiple options for tailoring biopsy workflows.
The features will initially be launched in a limited release, with a broader U.S. launch planned for 2026. As of June 30, 2025, over 900 Ion systems were in place across 10 countries, supported by over 100 abstracts and publications.
Intuitive is sponsoring clinical studies involving over 2,000 subjects in the EU and U.S.
Megan Elliott
megan.elliott@intusurg.com
+1 408-523-8181 ext. 6934681
Source: Intuitive Surgical, Inc.