Karl Storz Wins FDA Nod for Rubina Lens for Open Surgery

Karl Storz has earned U.S. Food and Drug Administration (FDA )clearance for its Rubina Lens exoscope for open surgery. The release broadens the company’s near-infrared (NIR) imaging ecosystem for open and minimally invasive procedures in the U.S.

The digital, camera-based exoscope displays a real-time, magnified 4K image of the surgical field on a monitor. Since it can switch into NIR imaging using indocyanine green (ICG), Rubina Lens helps reveal important information that can’t be seen with the naked eye to support more informed decisions during open surgery.

Rubina Lens is indicated for real-time tissue perfusion assessment, lymphatic mapping, and breast surgery. It’s designed for use in any open surgical procedure where NIR imaging with ICG may support intraoperative decision making.

It integrated with existing Karl Storz IMAGE1 S Rubina imaging platforms, enabling surgical teams to expand fluorescence capabilities without further capital investment. The exoscope can be used handheld or mounted on a holding arm to offer flexibility across surgical settings.

“The Rubina Lens extends real-time fluorescence visualization into open surgery, integrating seamlessly with existing OR platforms,” said Fernando Morales, VP, Surgical & OR Integration, KARL STORZ United States. “It enables surgeons to incorporate NIR imaging into open procedures without unnecessary complexity or workflow burden.”

In May, the company set up a strategic distribution partnership with Womed under which the former will serve as the exclusive U.S. distributor of Womed Leaf, a product approved by the FDA for treating women with intrauterine adhesions, also known as Asherman syndrome.