Karl Storz receives FDA clearance for Rubina Lens exoscope for open surgery

Karl Storz has received clearance from the U.S. Food and Drug Administration for its Rubina Lens exoscope for open surgery, extending the company's near-infrared imaging ecosystem across both open and minimally invasive procedures in the United States.

The digital, camera-based exoscope displays a real-time, magnified 4K image of the surgical field on a monitor. Surgeons can switch to near-infrared, or NIR, imaging using indocyanine green, a fluorescent dye commonly known as ICG, to reveal anatomical information that cannot be seen with the naked eye — a capability the company says supports more informed decision-making during open surgery.

"The Rubina Lens extends real-time fluorescence visualization into open surgery, integrating seamlessly with existing OR platforms," said Fernando Morales, vice president of surgical and OR integration at Karl Storz United States. "It enables surgeons to incorporate NIR imaging into open procedures without unnecessary complexity or workflow burden."

The device is indicated for real-time tissue perfusion assessment, lymphatic mapping and breast surgery, and is designed for use in any open procedure where NIR imaging with ICG may aid intraoperative decision-making. As with the company's fully endoscopic version, the exoscope offers surgeons several options for viewing the fluorescence imaging signal.

Because the Rubina Lens integrates directly with existing Karl Storz Image1 S Rubina imaging platforms, hospitals can expand their fluorescence capabilities without purchasing additional capital equipment, the company said. The exoscope can be used handheld or mounted on a holding arm.

The device is already approved in markets outside the United States. The FDA clearance brings the technology to U.S. surgeons performing open procedures, addressing what the company describes as a need for consistent visualization across surgical approaches.

Karl Storz, based in Tuttlingen, Germany, develops endoscopic technology and surgical imaging systems used across most surgical specialties.