News | Cybersecurity | June 19, 2024

Medical device manufacturers adopt Karamba’s XGuard Suite to meet customer demand and FDA cybersecurity regulations

Medical device manufacturers adopt Karamba’s XGuard Suite to meet customer demand and FDA cybersecurity regulations

June 19, 2024 —Karamba Security, a world leader in end-to-end product security, today announced the signing of a production agreement for its XGuard software, with Ziehm-Orthoscan, Inc., a manufacturer of industry-leading mini C-arm imaging devices specifically designed for orthopedic procedures. The agreement enables Ziehm-Orthoscan, Inc. to secure its imaging devices and comply with recent FDA cybersecurity regulations.

Ziehm-Orthoscan, Inc. sought a software solution that would meet stringent regulatory requirements and harden its devices against cyberattacks. The company selected Karamba Security’s XGuard software for its deep security features, such as allowlisting and data protection, to meet regulatory compliance. An important factor in selecting XGuard was its seamless integration, resulting in retrofitting Ziehm-Orthoscan's existing devices and meeting customer demand, motivated by the FDA regulation. XGuard functions as a bolt-on security layer to the device firmware and does not require R&D changes or product delays.

“Protecting our customers’ safety and privacy is a key mission for Ziehm-Orthoscan, Inc.,” said Robert Selke, VP Engineering. “We were looking for a solution that could be seamlessly applied to our products without delaying time to market, while providing strong security measures. We have found those qualities in Karamba Security’s XGuard, and we are excited to team up with this high-growth company.”

Karamba Security’s XGuard Suite is a comprehensive set of embedded software modules designed to address the evolving cybersecurity threats faced by IoT devices, such as automotive ECUs and medical devices. By integrating XGuard into its imaging devices, Orthoscan has implemented essential security features without disrupting the development or release schedules. XGuard software was applied as a bolt-on layer to Ziehm-Orthoscan firmware, which utilizes Ubuntu, a free, open-source operating system.

Key features of Karamba Security’s XGuard Suite include:

  • XGuard Device Security - added to existing firmware, provides critical security functions for runtime integrity without interfering with development timelines or requiring any R&D interference
  • XGuard Onboard Security - provides underlying security such as secure boot, cryptographic libraries and secure storage necessary for protecting medical devices at boot time
  • XGuard for Containers and VMs - extends security to containers and virtual machines, ensuring that they are instantiated from untampered images and securing applications during runtime
  • XGuard Monitor - enables continuous monitoring of security indicators for automated anomaly detection, offering real-time insights into both cybersecurity incidents and system health through customizable dashboards

“We welcome Ziehm-Orthoscan, Inc. to Karamba’s customer family that includes Fortune 500 and Global 500 Companies,” said Ami Dotan, Karamba co-founder and CEO. “The medical device market is becoming more connected and sophisticated, and as such represents a lucrative attack target for hackers. Ziehm-Orthoscan, Inc.'s management enhanced its global market dominance by ensuring its customers are protected against cyberattacks. We are privileged to partner with Ziehm-Orthoscan, Inc. on delivering a new level of security to the medical device market.”

For more information: www.karambasecurity.com


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