News
FOR IMMEDIATE RELEASE
ICS Launches SBOMGuard: A Powerful SBOM Tool Purpose-Built for
Medical Device Cybersecurity in a Complex Threat Landscape
ICS’ ‘Software Bill of Materials’ monitoring tool manages hidden risks in software stacks
and simplifies FDA postmarket compliance with an easy-to-use browser-based workflow.
WALTHAM, MA – DECEMBER 9, 2025 – ICS, at the forefront of embedded software development for regulated industries, today announced the launch of SBOMGuard, a new Software Bill of Materials (SBOM) analysis and vulnerability management tool built specifically for medical device manufacturers. SBOMGuard helps manage hidden risks in a software stack and simplifies FDA postmarket compliance with an easy-to-use browser-based workflow.
“Medical device manufacturers face unique challenges when it comes to cybersecurity and compliance,” said ICS CEO Peter Winston. “SBOMGuard gives them the visibility and tools they need to manage risk across the entire software lifecycle – fast, smart and in full alignment with FDA postmarket requirements.”
How SBOMGuard Works
SBOMGuard imports an SPDX-formatted SBOM and performs an automated scan of vulnerabilities using the NIST National Vulnerability Database (NVD). CVEs (Common Vulnerabilities and Exposures) are stored and versioned, with a record of status and justifications. With automated report generation and built-in differential analysis, SBOMGuard helps medtech firms maintain compliance with regulatory requirements and stay ahead of emerging security threats.
Key SBOMGuard features include:
- Cloud-Native Accessibility: Browser-based cloud-service with multi-user access
- Regulatory Readiness: Central part of compliance to FDA cybersecurity requirements for medical devices
- Efficient Workflows: Vulnerability workflow management designed for periodic updates
- Enhanced Insight: Supports NVD rescans and management by differential analysis
- Format-Flexible: Utilizes common formats, such as VEX, Cyclone DX and SPDX
“SBOMGuard empowers medtech companies to take control of their software supply chains and streamline cybersecurity readiness in an industry where speed, safety and regulatory alignment are mission-critical,” said Milton Yarberry, ICS’ Director of Medical Programs.
About ICS
ICS' product development team combines world-class embedded software engineering and UX design services, specializing in regulated industries including medical devices, aerospace, and industrial automation. For more than 30 years, ICS has helped companies bring intelligent, connected and secure products to market faster – everything from high-performance medical devices, in vitro diagnostic instruments and scientific software to embedded air traffic control systems, smart agri-business equipment and in-vehicle infotainment (IVI) systems for Tier-1 automakers. ICS also leverages artificial intelligence throughout its workflows to drive efficiency and innovation, and offers comprehensive AI consulting services to help companies harness the transformative potential of AI in their products and operations. ICS is headquartered in Waltham, Mass., with offices in Sunnyvale, California and Ottawa, Ontario.
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Media Contact:
Heidi Boie
hboie@ics.com
508-846-5307