KARL STORZ IMAGE1 S^® surgical video system earns highest cybersecurity certification

The advanced endoscopic camera system is the first on the market to achieve certification through the UL Cybersecurity Assurance Program 

EL SEGUNDO, CA (November 6, 2024) – KARL STORZ, a leader in endoscopic imaging and operating room (OR) integration, is proud to announce that the IMAGE1 S^® CONNECT II camera control unit has earned certification to UL 2900-2-1 through the UL Cybersecurity Assurance Program. UL 2900-2-1 is a national consensus standard published by the American National Standards Institute and recognized by the FDA as a path to fulfilling the agency’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, VP, Sales and Marketing, OR1 & Surgical, KARL STORZ United States. “This certification is important for purchasers who want to mitigate risks by sourcing products validated by a trusted third party,” she said, adding, “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 heart of the system, 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 industry-leading 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,” said Gaudet. “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. Last year, 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 said. “The risks of a cyberattack—particularly in terms of cost and disruptions to care—are simply too great to ignore.”