Medcrypt Unveils Enhanced Helm SBOM Vulnerability Management Tool: The First Industry-Specific Solution for Medical Device Manufacturers

Helm streamlines compliance, reduces risk, and delivers superior quality—helping manufacturers meet cybersecurity regulations faster and more efficiently.

SAN DIEGO, Feb. 19, 2025 /PRNewswire/ — Medcrypt, a leader in medical device cybersecurity, has announced enhanced capabilities for Helm, its SBOM Vulnerability Management Tool built specifically for medical device manufacturers (MDMs). Helm now outpaces generic SBOM solutions by providing industry-specific features that reduce compliance burdens, lower risk, and improve efficiency – all while cutting costs and accelerating time to market. Learn more and request a demo.

Why Helm? Purpose-Built for Medical Device Manufacturers

Unlike general-purpose security tools, Helm is purpose-built for MDMs, tackling compliance, security and lifecycle management challenges. Helm incorporates features such as FDA ready SBOM reports, auto-rescoring of vulnerabilities, and audit ready documentation, ensuring manufacturers meet regulatory expectations efficiently. These capabilities help manufacturers navigate FDA submissions, streamline audits and reduce security risks – all while maintaining product innovation timelines.

What Sets Helm Apart?

• Faster Time to Compliance: Helm automates manual tasks, reducing the time required for SBOM management, vulnerability dispositioning, and regulatory preparation.
• Reduced Security Risk: Helm enhances vulnerability management by improving component matching accuracy and reducing false positives. This ensures security teams focus on critical threats rather than wasting time filtering out irrelevant CVEs.
• Efficient Lifecycle Management: Create automated EOS/EOL lifecycle rules to track components across portfolios. Intuitive status indicators highlight components approaching or past EOS/EOL, helping teams to prioritize upgrades and manage risks proactively.
• Superior Quality & Accuracy: By automating risk and compliance management, Helm reduces human error, providing more precise, consistent security documentation. Helm outperformed competitors in component matching accuracy and associated vulnerability identification, eliminating false positives and freeing teams to focus on high-impact threats.
• Lower Operational Costs: Automating compliance tasks reduces engineering hours spent on compliance and security tasks. Additionally, Helm’s lower false positive rate minimizes unnecessary fixes, allowing teams to focus on real threats and device innovation.
• Industry-Standard SBOM & FDA-Ready Reports: Helm generates on-demand, exportable SBOMs, in CycloneDX and SPDX formats to meet industry standards. It also provides FDA-ready vulnerability disclosure reports (VDR), VEX, and other critical reports to streamline audits and regulatory submissions. These reports are backed by insights from former FDA reviewers who have shaped medtech cybersecurity policies.
• Integrations for Seamless Workflow: Integrate Helm into your CI/CD pipeline to ensure SBOMs align with the latest builds. Leverage our API, GitHub action, upcoming Azure DevOps extension, or manually create or upload SBOMs. Automatically pull vulnerabilities—such as those on the CISA KEV—via our API, then integrate them into your ticketing system using a custom script or external workflow (Jira integration coming soon).
• Proven Industry Trust: Medcrypt actively collaborates with regulatory bodies and industry stakeholders, ensuring Helm is always aligned with the latest cybersecurity and compliance expectations while also helping shape the future of medtech cybersecurity.

Executive Perspective

“Over my many years in the cybersecurity space, and working on global industry best practices and specifications, I have witnessed the immense pressure MDMs are under to meet evolving cybersecurity regulations while keeping costs and operational burdens in check,” said Bob Lyle, Chief Revenue Officer at Medcrypt. “Helm is designed specifically to accelerate compliance, improve security, and reduce the cost of meeting FDA expectations. By automating processes and enhancing accuracy, Helm allows manufacturers to spend less time on compliance and more time driving innovation and patient safety.”

As cybersecurity enforcement intensifies and the industry navigates challenges such as the slowdown in NVD data processing, MDMs need an industry-specific solution – not a repurposed tool. Helm enables manufacturers to future-proof compliance, streamline security efforts, and focus on innovation and patient safety.

Learn More About Helm

• Request a Helm Demo
• Read More on EOL/EOS Challenges

For more information on Helm, visit www.medcrypt.com.

About MedCrypt

Medcrypt is helping healthcare technology companies ensure medical devices are secure by design. We provide cybersecurity products and strategic management consulting to expedite the go-to-market process of medical device manufacturers’ new life-saving connected technologies. Founded in 2016 by a team of healthcare cybersecurity experts, Medcrypt is uniquely positioned to be the security catalyst for medical device manufacturers to design secure, FDA-approved technologies. We continue to work with those paving the way toward safe and reliable medtech.

To date, Medcrypt has raised more than $36 million in funding with participation from Johnson & Johnson Innovations, Intuitive Ventures, and Dexcom Ventures. For more information, please visit www.Medcrypt.com.

Press Contact

Jenny Bourne
2087618447
https://www.medcrypt.com/

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SOURCE MedCrypt