KARL STORZ Receives FDA Clearance for Rubina Lens Exoscope for Open Surgery

KARL STORZ, a global leader in endoscopic and minimally invasive surgical technology, has announced FDA clearance for the Rubina Lens exoscope for open surgery, broadening the company’s near-infrared imaging ecosystem across 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. With the ability to switch into near-infrared imaging using indocyanine green, the device helps reveal information invisible to the naked eye.

The Rubina Lens is designed for real-time tissue perfusion assessment, lymphatic mapping, and breast surgery, and can be used in any open surgical procedure in which near-infrared imaging with indocyanine green may support intraoperative decision making. By integrating directly with existing KARL STORZ IMAGE1 S Rubina imaging platforms, the Rubina Lens enables surgical teams to expand fluorescence capabilities without additional capital investment. The exoscope can be used handheld or mounted on a holding arm, providing flexibility across surgical settings.

Fernando Morales, Vice President of Surgical and OR Integration at KARL STORZ United States, said the Rubina Lens extends real-time fluorescence visualization into open surgery, integrating seamlessly with existing operating room platforms. He noted that it enables surgeons to incorporate near-infrared imaging into open procedures without unnecessary complexity or workflow burden.

Already approved for use in markets outside the United States, the Rubina Lens brings proven near-infrared imaging technology to U.S. surgeons performing open procedures, addressing the need for consistent visualization across surgical approaches.