Continuously refined by in-house former FDA reviewers, Helm transforms overwhelming vulnerability data into actionable insights — enabling medical device teams to focus on critical risks while ensuring regulatory compliance with one-click FDA-ready reporting.
Unlike generic cybersecurity tools that generate thousands of irrelevant alerts, Helm's AI-powered platform identifies only the vulnerabilities that impact your specific medical devices.
Three of the top five medical device manufacturers trust Helm to streamline FDA submissions while maintaining the highest standards of patient safety.
Proven superior accuracy in head-to-head competitive testing.
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Streamline vulnerability management across your medical device portfolio with our platform designed by former FDA reviewers. Unlike generic cybersecurity tools, Helm is purpose-built for the unique challenges medical device manufacturers face with regulatory compliance and patient safety.
Take advantage of our powerful API and integration options to continuously ingest SBOM updates, or choose to manually create or upload SBOMs, automatically match components using our powerful alias rules engine. Immediately rescore your product portfolio to reflect each device's unique security context.
Helm leverages medical device-specific exploitability sources including EPSS, CISA KEV, ExploitDB, Metasploit, CWE Top 25, and NVD to help you focus on the vulnerabilities that pose real risk to patient safety and your bottom line. Minimize false positives with AI-powered intelligence that detects affected tech stacks.
Get both short-term mitigations and upgrade paths tailored to medical device environments. Then bulk remediate vulnerabilities and import vulnerability remediation across your device portfolio, enabling consistent vulnerability management at scale.
Automatically generate single or multi-product compliance-ready reports including CDX and SPDX SBOMs, VEX, VDR, vulnerabilities reports, and our proprietary Medcrypt FDA SBOM to streamline regulatory submissions and audits.
You're responsible for securing complex, multi-component medical devices with a growing software attack surface, but existing tools aren't built for medical device reality. You need automated prioritization, accurate matching, and scalable reporting that keeps pace with FDA expectations.
Upload or manually create SBOMs (CycloneDX or SPDX) with ease—or plug Helm into your CI/CD pipeline via API, GitHub Actions, Azure DevOps, or other integrations. This ensures your supply chain view is always precise and current.
Helm uses risk intelligence from EPSS, CISA KEV, ExploitDB, and Metasploit, as well as leveraging powerful AI-powered guidance to detect vulnerable tech stacks and recommend mitigations or upgrade paths for your vulnerabilities. This helps you cut through the noise and focus remediation on the issues that matter most.
Use Helm's bulk rescoring and auto-rescoring to adjust vulnerability impact across product versions. Bulk remediate and import remediation across versions, minimizing rework. Leverage our powerful rules engine to automate vulnerability identification and lifecycle tracking. Generate FDA-ready SBOMs, VEX, and VDR reports with one click.
Leverage Helm’s rules engine to standardize metadata hygiene across products — create alias rules for more accurate, consistent component matching and lifecycle rules to automate EOS/EOL and support-level data. These rules help ensure audit-ready consistency and smooth regulatory alignment.
Helm enables one-click export of the Medcrypt FDA SBOM—built by former FDA reviewers—as well as FDA-compliant CycloneDX or SPDX SBOMs, plus VEX and VDR vulnerability reports. Historical snapshots are stored in your report history for audit-ready visibility across product versions.
Seamlessly embed Helm into your DevSecOps workflows using our API, GitHub Action, or Azure DevOps integration.
Automate SBOM ingestion and vulnerability detections directly within build pipelines, ensuring consistent security at every release phase.
Leverage AI-powered analytics to rank vulnerabilities in real time, detecting affected tech stacks and providing short-term and upgrade recommendations. Helm uses data from EPSS, CISA KEV, ExploitDB, Metasploit, NVD, and CWE Top‑25 to accurately gauge exploitability.
Bulk rescore vulnerabilities according to your device security posture, apply cross-version remediation, and automate Windows CVE patching in a single streamlined workflow.
Manage SBOM consistency at scale using Helm’s automated rules engine. All rules apply automatically across existing and future SBOMs, saving time and reducing errors.
Alias rules help resolve unmatched, mismatched, or ambiguous components by mapping them to verified software entries from the NVD — improving vulnerability matching and accuracy.
Lifecycle rules apply Level of Support and EOS/EOL metadata across your portfolio to simplify FDA reporting and keep support status current.
Automatically enrich and maintain SBOM and vulnerability metadata: import missing license info, correct CPEs/PURLs, refresh severity and exploitability details, auto-rescore vulnerabilities as fix data arrives, and auto-patch Ubuntu CVEs that were fixed upstream.
The result: low-effort, audit-ready inventories.
Generate single or multi-product FDA-compliant reports with one click, including our proprietary FDA SBOM, built by former FDA reviewers.
Export CycloneDX and SPDX SBOMs, VDRs, VEX, and more to ensure regulatory compliance and accelerate your time-to-market. Access your report history at any time.
Unlike general-purpose SBOM tools, Helm is engineered specifically for the medical device industry—built around FDA and NTIA cybersecurity needs rather than trying to serve every sector. It combines industry‑focused SBOM management, tailored vulnerability analytics, and compliance-ready outputs into a unified platform.
In head‑to‑head testing against leading competitors, Helm demonstrated superior accuracy, identifying more valid vulnerabilities and matching components more reliably than competitor tools—while producing zero classified false positives.
These results underscore Helm’s emphasis on precision — eliminating noise, boosting accuracy in dependency matching, and minimizing false alarms — helping medical device security teams focus on what matters most.
Get your free copy of the Helm datasheet for more on how
Helm's automated platform helps you align with FDA methodology.