Medcrypt’s enhanced SBOM Vulnerability Management Tool is reported to help manufacturers streamline compliance and reduce security risks.
SAN DIEGO— As cybersecurity enforcement intensifies, the medical device industry must navigate challenges such as the slowdown in NVD data processing. As a result, device manufacturers (MDMs) need an industry-specific cybersecurity tool, according to medical device cybersecurity company Medcrypt.
Medcrypt recently announced enhanced capabilities for Helm, its Software Bill of Materials (SBOM) Vulnerability Management Tool. Unlike general-purpose security tools, Helm is built specifically for medical device manufacturers (MDMs), tackling compliance, security, and lifecycle management challenges, according to a release from Medcrypt.
By incorporating features such as U.S. FDA-ready SBOM reports, auto-rescoring of vulnerabilities, and audit ready documentation, Helm helps manufacturers meet regulatory expectations efficiently. These capabilities are reported to assist manufacturers in navigating FDA submissions, streamlining audits, and reducing security risks while maintaining product innovation timelines.
“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,” the company said in the release.
By automating manual tasks, Helm is said to facilitate faster time to compliance, reducing the time required for SBOM management, vulnerability dispositioning, and regulatory preparation. It reduces security risk with enhanced vulnerability management that improves component matching accuracy and decreases false positives, according to Medcrypt.
“This ensures security teams focus on critical threats rather than wasting time filtering out irrelevant CVEs,” the release stated.
Medcrypt said in the release that it actively collaborates with regulatory bodies and industry stakeholders, ensuring that “Helm is aligned with the latest cybersecurity and compliance expectations while also helping shape the future of medtech cybersecurity,” the company said.
“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, in the release. “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.”
Founded in 2016 by a team of healthcare cybersecurity experts, Medcrypt said it is “uniquely positioned to be the security catalyst for medical device manufacturers to design secure, FDA-approved technologies.”
“Medcrypt is helping healthcare technology companies ensure medical devices are secure by design,” the company said in the release. “We provide cybersecurity products and strategic management consulting to expedite the go-to-market process of medical device manufacturers’ new life-saving connected technologies.”
To date, Medcrypt is reported to have raised more than $36 million in funding with participation from Johnson & Johnson Innovations, Intuitive Ventures, and Dexcom Ventures.