KARL STORZ’s IMAGE1 S CONNECT II camera control unit has earned UL 2900-2-1 certification through the UL Cybersecurity Assurance Program. UL 2900-2-1 is a national consensus standard published by the American National Standards Institute and is a way for companies to fulfill the U.S. Food and Drug Administration’s cybersecurity testing recommendations for medical devices.

“Certification to the UL 2900 series of standards is the highest recognition of cybersecurity due diligence and helps demonstrate that a product or system is secure to modern standards,” said Christy Gaudet, Sales and Marketing vice president, OR1 & Surgical, at KARL STORZ United States. “This certification is important for purchasers who want to mitigate risks by sourcing products validated by a trusted third party. IMAGE1 S is the first and only surgical camera system to achieve this certification.”

IMAGE1 S is a modular, scalable endoscopic imaging platform that allows users to add functionality as needed. The CONNECT II camera control unit is the system’s heart, enabling separate modules for working with rigid and flexible endoscopes in HD, 4K, 3D, and NIR/ICG imaging modes. It’s a vital component of the OR integration solutions provided by KARL STORZ.

“Designed for modularity and backward and forward compatibility, IMAGE1 S gives users the confidence of knowing their surgical imaging equipment reflects the latest technical advances,” Gaudet stated. “ULCAP certification gives them the further confidence of knowing their equipment has been rigorously tested against the latest cyberthreats—a major concern for healthcare network administrators.”

ULCAP certification is part of a longstanding effort at KARL STORZ to meet the most stringent cybersecurity requirements. In 2023, KARL STORZ became the first provider of OR integration solutions to receive an Authorization to Operate (ATO) from the U.S. Department of Defense (DoD), Defense Health Agency (DHA). The company’s flagship OR integration products cleared extensive IT security and privacy controls and was deemed secure within certain deployment parameters for operation in military hospitals, clinics, and medical facilities.

“Cybersecurity isn’t an afterthought at KARL STORZ, it’s an integral part of our design process,” Gaudet stressed. “The risks of a cyberattack—particularly in terms of cost and disruptions to care—are simply too great to ignore.”

For nearly 80 years, KARL STORZ has developed and provided endoscopic technology and surgical imaging across virtually all surgical specialties. Its integrated OR solutions are intended to enhance collaboration to improve clinical efficiency and outcomes inside the hospital and other sites of care. KARL STORZ is a family-owned company based in Tuttlingen, Germany, that designs, engineers, manufactures, and markets all its products with an emphasis on visionary design, precision craftsmanship, and clinical effectiveness.