KARL STORZ has received clearance from the US Food and Drug Administration (FDA) for its RUBINA Lens exoscope, authorising its use for open surgery.
The exoscope offers digital, camera-based imaging and extends the company’s near-infrared (NIR) imaging options to both open and minimally invasive surgical procedures.
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The device presents a real-time, magnified 4K view of the surgical area on a monitor.
It enables surgeons to shift between standard imaging and NIR imaging using indocyanine green (ICG), which may allow for additional information that is not visible to the naked eye.
According to Karl Storz, this capability is designed to support more informed intraoperative decisions.
Karl Storz US surgical and OR integration vice-president Fernando Morales said: “The Rubina Lens extends real-time fluorescence visualisation into open surgery, integrating seamlessly with existing OR platforms. It enables surgeons to incorporate NIR imaging into open procedures without unnecessary complexity or workflow burden.”
The RUBINA Lens is intended for real-time tissue perfusion assessment, lymphatic mapping, and breast surgery. It can be used in any open operation where NIR imaging with ICG might assist clinical decision-making.
Similar to the company’s fully endoscopic systems, the device offers surgeons multiple viewing options for the NIR/ICG fluorescence image.
It can connect with the existing Karl Storz IMAGE1 S RUBINA imaging platforms, allowing surgical teams to expand NIR fluorescence imaging without requiring new capital equipment.
The exoscope can be handheld or secured to a holding arm, offering flexibility across various surgical settings.
Additional features include compatibility with sterilisation processes, a wide working distance designed to reduce the need for frequent refocusing, a large field of view in a 16:9 format, and manual horizon control for orientation and positioning.
Before FDA clearance, the RUBINA Lens exoscope had already been approved for use in markets outside the US.
