Medcrypt, a leader in medical device cybersecurity, has announced enhanced capabilities for Helm, its SBOM Vulnerability Management Tool designed specifically for medical device manufacturers (MDMs). Helm now surpasses generic SBOM solutions by providing industry-specific features that streamline compliance, reduce risk, and improve efficiency, helping manufacturers meet FDA cybersecurity regulations faster and more effectively while reducing costs and accelerating time to market.

Unlike general-purpose security tools, Helm is purpose-built for MDMs, addressing compliance, security, and lifecycle management challenges unique to the medical device industry. Helm incorporates key features such as FDA-ready SBOM reports, auto-rescoring of vulnerabilities, and audit-ready documentation, ensuring manufacturers can navigate regulatory requirements with greater ease and efficiency. By automating traditionally manual processes, Helm reduces the burden on engineering teams, enabling them to focus on innovation and patient safety rather than compliance-related tasks.

One of Helm’s standout capabilities is its ability to enhance vulnerability management by improving component matching accuracy and reducing false positives. This ensures security teams can concentrate on addressing critical threats rather than spending time filtering out irrelevant Common Vulnerabilities and Exposures (CVEs). Helm also introduces an automated approach to tracking component lifecycle stages, helping teams manage end-of-service (EOS) and end-of-life (EOL) risks more proactively.

The tool’s efficiency extends beyond compliance by improving overall security documentation accuracy. By automating compliance-related tasks, Helm minimizes human error, leading to more consistent and precise risk assessments. The system has demonstrated superior performance in component matching accuracy and vulnerability identification compared to other SBOM tools, eliminating false positives and freeing security teams to focus on high-impact threats.

Helm also reduces operational costs by optimizing the compliance process. By lowering false positive rates and eliminating unnecessary remediation efforts, manufacturers can allocate more resources to advancing medical device innovation. Additionally, Helm provides industry-standard SBOM and FDA-ready reports in CycloneDX and SPDX formats, streamlining regulatory submissions. With reports such as Vulnerability Disclosure Reports (VDR) and VEX, manufacturers can meet industry and regulatory expectations with ease.

The solution integrates seamlessly into CI/CD pipelines to ensure SBOMs align with the latest builds. Helm offers flexible integration options, including APIs, GitHub actions, an upcoming Azure DevOps extension, and Jira integration in the near future. Users can also automate the retrieval of vulnerability data from trusted sources, such as the Cybersecurity and Infrastructure Security Agency (CISA) Known Exploited Vulnerabilities (KEV) catalog, ensuring real-time updates on emerging threats.

Medcrypt actively collaborates with regulatory bodies and industry stakeholders, ensuring Helm remains aligned with the latest cybersecurity and compliance standards while shaping the future of medtech cybersecurity. As enforcement of cybersecurity regulations continues to intensify, medical device manufacturers require industry-specific solutions rather than repurposed tools from other industries.

Bob Lyle, Chief Revenue Officer at Medcrypt, emphasized the growing need for dedicated solutions. “Over my many years in the cybersecurity space and working on global industry best practices and specifications, I have witnessed the immense pressure MDMs face in meeting evolving cybersecurity regulations while keeping costs and operational burdens in check. 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.”

With cybersecurity concerns growing and new challenges such as the slowdown in National Vulnerability Database (NVD) data processing, MDMs must adopt future-proof solutions. Helm equips manufacturers with the tools they need to streamline security efforts, maintain compliance, and focus on bringing safe and innovative medical devices to market.