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Intuitive gets expanded FDA nod for AI, imaging integration for Ion

Intuitive Surgical (Nasdaq: ISRG) has secured expanded FDA clearance for new software capabilities that bring advanced artificial intelligence (AI) and imaging integration to its Ion endoluminal robotic platform — a move that further strengthens the company’s leadership in minimally invasive lung care.

The Ion robotic bronchoscopy system, first cleared by the FDA in 2019, is a catheter-based robotic platform designed to enable precise, minimally invasive biopsies deep within the lungs. Using a shape-sensing, ultra-thin catheter with fiber optic sensors along its length, Ion can navigate complex airways and access small, hard-to-reach pulmonary nodules that are often early indicators of lung cancer. Its precision and flexibility have made it a cornerstone of modern diagnostic bronchoscopy.

With the latest software upgrade, Intuitive is embedding AI across Ion’s entire navigational workflow, integrating computer vision, predictive modeling, and real-time data analysis to improve accuracy and efficiency during biopsy procedures. The system’s enhanced imaging capabilities now provide physicians with a richer, more adaptive view inside the lung, allowing for tailored, data-driven navigation that adjusts dynamically to patient anatomy and motion.

According to Intuitive, these innovations directly address one of the biggest challenges in robotic-assisted lung biopsy: CT-to-body divergence — when a lung nodule appears in a different position during the procedure compared to its location on the preoperative CT scan due to breathing or patient movement. Traditionally, this phenomenon can complicate navigation and reduce procedural success rates. By fusing AI-powered image recognition with real-time shape sensing, Ion can now automatically adjust its trajectory mid-procedure, helping clinicians maintain accurate targeting and reduce the need for manual corrections.

Beyond navigation, Intuitive’s software update introduces advanced imaging features such as integrated tomosynthesis, which enables real-time imaging updates using a standard 2D C-arm. This capability allows surgeons to generate layered, near-3D visualizations without the need for expensive or bulky external imaging equipment. As a result, Ion’s latest generation supports faster procedures, higher diagnostic confidence, and improved patient throughput — key priorities for hospitals facing growing demand for early lung cancer detection.

“These latest Ion software advancements reflect Intuitive’s ongoing commitment to advancing lung cancer care through meaningful innovation,” said Dave Rosa, CEO of Intuitive Surgical. “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.”

The new AI-powered features come just a month after Intuitive announced expanded surgical data insights for its flagship da Vinci surgical system, showing the company’s broader push to connect robotics, analytics, and imaging across its entire portfolio. Collectively, these developments align with Intuitive’s long-term goal of creating intelligent, adaptive robotic ecosystems that enhance surgical precision while improving efficiency across multiple specialties.

As of mid-2025, Intuitive reports over 900 Ion systems deployed globally across more than 10 countries. The company plans a limited initial rollout of the new software to gather performance insights, followed by a broader launch in 2026, as it continues to refine the system based on clinical feedback and real-world outcomes.

Intuitive’s newly cleared software suite for the Ion endoluminal robotic platform marks a pivotal step toward fully intelligent robotic-assisted diagnostics — where artificial intelligence, advanced imaging, and real-time sensing converge to transform how physicians detect and treat lung cancer. The integration of AI into Ion’s navigational workflow isn’t just an incremental update; it represents a shift toward a new generation of data-driven robotic systems capable of adapting to patient-specific variations with unprecedented precision.

At the core of these enhancements is an AI-powered navigation algorithm that continuously interprets imaging data and the shape-sensing feedback from Ion’s flexible catheter. By analyzing subtle shifts in the anatomy — caused by breathing, tissue deformation, or patient movement — the algorithm can automatically adjust the navigation pathway in real time. This helps overcome the notorious CT-to-body divergence issue that often challenges conventional bronchoscopy. The system cross-references live fluoroscopic images with the original preoperative CT scan, re-aligning the visual map and ensuring that the physician’s route to the target nodule remains accurate, even as the patient’s anatomy shifts during the procedure.

This real-time correction significantly boosts diagnostic yield by increasing the probability of accurately reaching and sampling small, hard-to-access nodules. For clinicians, it also simplifies workflow — reducing manual repositioning and imaging adjustments that can prolong procedures and increase radiation exposure. The AI essentially serves as a co-pilot, augmenting the physician’s situational awareness and providing actionable insights without interrupting the procedural flow.

Complementing this AI-driven precision is the new integrated tomosynthesis imaging capability. Traditionally, interventional pulmonologists rely on static 2D imaging, which offers limited depth perception. Tomosynthesis overcomes this by reconstructing layered cross-sectional images from multiple 2D angles captured using a standard C-arm. This produces a near-3D visualization of the lung in real time, empowering physicians to confirm catheter position and tool alignment without resorting to full CT scans. The result is greater confidence in needle placement and higher biopsy accuracy, even in challenging or mobile targets.

“Early diagnosis can make a life-changing difference for patients with lung cancer,” said Federico Barbagli, SVP and GM for 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.”

These capabilities also have the potential to extend Ion’s utility beyond diagnosis. As real-time image guidance and adaptive navigation evolve, Ion could eventually support therapeutic interventions, such as localized ablation or drug delivery within the lung. By merging diagnostic and interventional workflows, Intuitive aims to create an integrated ecosystem for lung disease management, aligning with its broader vision of connected, intelligent surgical care.

Clinicians testing the new Ion software in early trials have reported smoother workflows, more predictable navigation, and improved procedural efficiency. Hospitals participating in the limited rollout have also noted shorter procedure times and fewer instances of repeat biopsies, suggesting that AI integration could yield both clinical and economic benefits.

From a strategic standpoint, these advancements strengthen Intuitive’s position at the forefront of robotic bronchoscopy — a rapidly growing market driven by rising global lung cancer incidence and the need for early, minimally invasive diagnosis. The company is expected to continue expanding Ion’s footprint worldwide, with plans to integrate data analytics, telepresence capabilities, and cross-platform interoperability between Ion and the da Vinci systems in future updates.

The introduction of AI into Ion’s workflow also aligns with Intuitive’s broader push toward surgical intelligence, where machine learning models learn from millions of recorded procedures to provide real-time decision support and predictive insights. By uniting robotic dexterity, imaging precision, and AI reasoning, Intuitive is moving closer to its long-term goal: enabling a world where surgical systems learn, adapt, and assist autonomously while keeping clinicians firmly in control.

As of June 2025, more than 900 Ion systems are operational across hospitals in 10 countries, a figure expected to grow as these new features roll out globally. The expanded FDA clearance cements Ion’s status as a next-generation platform in robotic-assisted diagnostics — one that doesn’t just enhance human skill, but evolves alongside it.

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