KARL STORZ Announces FDA Clearance for Rubina Lens for Open Surgery

Powerful technology lets surgeons incorporate NIR/ICG imaging into open procedures

EL SEGUNDO, Calif.--(BUSINESS WIRE)--KARL STORZ, a global leader in endoscopic and minimally invasive surgical technology, has received FDA clearance for the Rubina™ Lens exoscope for open surgery, broadening the company’s near-infrared (NIR) imaging ecosystem across open and minimally invasive procedures in the United States.

The digital, camera‑based Rubina™ Lens exoscope displays a real‑time, magnified 4K image of the surgical field on a monitor. With the ability to switch into NIR imaging using indocyanine green (ICG), the Rubina™ Lens exoscope helps reveal important information that cannot be seen with the naked eye, supporting 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, Surgical & OR Integration, KARL STORZ United States. “It enables surgeons to incorporate NIR imaging into open procedures without unnecessary complexity or workflow burden.”

The Rubina™ Lens is indicated for real-time tissue perfusion assessment, lymphatic mapping, and breast surgery and is designed for use in any open surgical procedure where NIR imaging with ICG may support intraoperative decision making. As with the fully endoscopic version, Rubina™ Lens gives the surgeon several options for viewing the NIR/ICG fluorescence imaging signal. 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.

Already approved for use in markets outside the United States, the Rubina™ Lens exoscope brings proven NIR imaging technology to US surgeons performing open procedures, addressing the need for consistent visualization across surgical approaches. To learn more about Rubina™ Lens for open surgery and other KARL STORZ NIR/ICG imaging solutions, visit karlstorz.com.

About KARL STORZ

KARL STORZ is an innovative leader in endoscopic technology and surgical imaging across virtually all surgical specialties. The company’s advanced imaging and integration solutions are designed to enhance collaboration to improve clinical efficiency and outcomes inside the hospital and other sites of care. Based in Germany, KARL STORZ is a global family-owned company that designs, engineers, manufactures, and markets all its products with an emphasis on visionary design, precision craftsmanship, and clinical effectiveness. For more information, visit www.karlstorz.com.