Helm automates SBOM ingestion, risk prioritization, and FDA-ready reporting — so you can focus on what’s exploitable, fixable, and regulatory-critical.
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Helm is a vulnerability management platform built specifically for medical device manufacturers. Take advantage of our powerful API and integration options to continuously ingest SBOM updates, or choose to manually create or upload SBOM, then immediately rescore your entire product version to reflect your device’s security context.
Leveraging exploitability sources including EPSS, CISA KEV, ExploitDB, Metaploit, CWE Top 25, NVD, and many other sources, you can rest assured you're focused on the most exploitable vulnerabilities that will have the biggest impact to your bottom line.
Helm also provides AI-powered intelligence, detects affected tech stacks, as well as providing both short‑term mitigations and upgrade paths. These insights power bulk remediation workflows and feed into compliance-ready reports like VEX, VDR, and our proprietary Medcrypt FDA SBOM.
You’re responsible for securing complex, multi-component medical devices with a growing software attack surface. Your SBOM contains more vulnerabilities than your team can handle manually, and many tools don’t account for your device’s unique environment, patient safety impact, or regulatory requirements. 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 per 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 rule engine. 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. All rules apply automatically across existing and future SBOMs, saving time and reducing errors.
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, 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.