KARL STORZ Secures FDA Clearance for RUBINA Lens, Expanding Fluorescence Imaging into Open Surgery

KARL STORZ has received US Food and Drug Administration (FDA) clearance for its RUBINA Lens exoscope, enabling the company to bring its near-infrared (NIR) fluorescence imaging technology into open surgical procedures. The approval extends the reach of KARL STORZ’s imaging ecosystem beyond minimally invasive surgery, allowing surgeons to access real-time fluorescence visualisation during a wider range of operations without requiring major changes to existing operating room infrastructure.

Bringing Advanced Visualisation to Open Surgery

The RUBINA Lens is a digital, camera-based exoscope that provides surgeons with a magnified 4K view of the surgical field displayed on a monitor.

The system allows clinicians to switch between standard white-light imaging and near-infrared fluorescence imaging using indocyanine green (ICG), a fluorescent dye commonly used to assess blood flow and tissue perfusion during surgery.

By combining these imaging modes, the device can reveal anatomical and physiological information that may not be visible to the naked eye, potentially supporting more informed intraoperative decision-making.

The FDA clearance covers use cases including:

• Real-time tissue perfusion assessment

• Lymphatic mapping procedures

• Breast surgery applications

• Other open surgical procedures where NIR imaging with ICG may provide clinical value
  

Expanding Existing Surgical Imaging Infrastructure

One of the key advantages of the RUBINA Lens is its ability to integrate with existing KARL STORZ imaging platforms.

The exoscope connects directly to the company's IMAGE1 S RUBINA systems, allowing hospitals already using KARL STORZ equipment to expand fluorescence-guided surgery capabilities without purchasing entirely new imaging infrastructure.

This reflects a broader trend across surgical technology, where manufacturers are increasingly focused on extending the functionality of existing platforms rather than requiring complete equipment replacement.

According to KARL STORZ, the system has been designed to fit naturally into existing operating room workflows while minimising procedural complexity.

Designed for Surgical Flexibility

The RUBINA Lens can be operated either as a handheld device or mounted to a holding arm, providing flexibility across different surgical environments and procedural requirements.

Additional features include:

• High-resolution 4K imaging

• Wide working distance to reduce frequent refocusing

• Large 16:9 field of view

• Manual horizon control for image orientation

• Compatibility with standard sterilisation processes

• Multiple fluorescence viewing modes similar to those available in the company's endoscopic systems
  

These capabilities are intended to support surgeon comfort while maintaining visual consistency across both open and minimally invasive procedures.

Why Fluorescence-Guided Surgery Matters

Fluorescence imaging has become an increasingly important tool across a growing range of surgical specialties.

By using dyes such as indocyanine green, surgeons can visualise blood flow, tissue perfusion and lymphatic structures in real time, helping to identify critical anatomy and assess tissue viability during procedures.

The technology has gained traction because it provides functional information beyond traditional visual inspection, offering an additional layer of data during surgery without significantly disrupting workflow.

As healthcare systems continue to prioritise precision surgery and improved patient outcomes, fluorescence-guided imaging is becoming an increasingly common component of modern operating rooms.

What This Means for the Industry

The FDA clearance of the RUBINA Lens highlights several broader trends in surgical technology:

• Advanced imaging capabilities are increasingly moving beyond minimally invasive procedures into open surgery

• Hospitals are seeking technologies that integrate with existing operating room infrastructure

• Fluorescence-guided surgery continues to expand across multiple clinical specialties

• Digital visualisation platforms are becoming central to modern surgical workflows

The approval also reinforces the growing importance of real-time imaging technologies that provide surgeons with enhanced visibility and decision support during procedures.

Summary

KARL STORZ has secured FDA clearance for the RUBINA Lens exoscope, extending its near-infrared fluorescence imaging capabilities into open surgery.

By combining 4K visualisation with real-time fluorescence imaging and compatibility with existing KARL STORZ platforms, the device supports a growing industry shift towards image-guided surgical procedures that enhance intraoperative decision-making while fitting seamlessly into established operating room workflows.

---

Discover how nuaxia can support your next medical education initiative:

• Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector 

• Contact us on: support@nuaxia.com