Helm
Vulnerability management platform for medical devices with automated SBOM and compliance reporting.
Vendor Information
Helm Overview
Helm is a Software Bill of Materials (SBOM) vulnerability management platform that automates creation, analysis, and validation of software supply chain data to identify and remediate cybersecurity risks in medical device software components while meeting Food and Drug Administration (FDA) premarket submission requirements. Built by former FDA reviewers, Helm eliminates up to 95% of false positives generated by generic cybersecurity tools through AI-powered intelligence that detects affected technology stacks and medical device-specific exploitability analysis, enabling engineering teams to focus on vulnerabilities that pose real risk to patient safety rather than investigating thousands of irrelevant alerts.
The platform integrates into development pipelines to automate SBOM ingestion and vulnerability detection at every build phase, continuously monitoring software components against Exploit Prediction Scoring System (EPSS), Cybersecurity and Infrastructure Security Agency (CISA) Known Exploited Vulnerabilities (KEV), ExploitDB, Metasploit, National Vulnerability Database (NVD), and Common Weakness Enumeration (CWE) Top 25 databases while providing bulk rescoring across product versions, automated remediation workflows with short-term mitigations and upgrade paths, and rule-based compliance automation including alias rules for consistent component matching and lifecycle rules for End of Support/End of Life metadata management.
Founded in 2016 and headquartered in Solana Beach, California, MedCrypt serves three of the top five medical device manufacturers with Helm demonstrating superior accuracy in head-to-head testing against leading competitors including Grype, Dependency Track, and BlackDuck by identifying more valid vulnerabilities while producing zero classified false positives. The platform generates FDA-ready reports including proprietary Medcrypt FDA SBOM format, CycloneDX and Software Package Data Exchange (SPDX) formats, Vulnerability Exploitability eXchange (VEX), and Vulnerability Disclosure Report (VDR) documentation with one-click export and historical snapshot storage for audit-ready visibility across medical device portfolios.
Key Capabilities
Standardized capabilities mapped to this product's security niche
Discovers and classifies connected medical devices by device type, manufacturer, model, and firmware version, including devices that do not support standard endpoint agents.
Maps identified vulnerabilities, network exposure, and control gaps to HIPAA Security Rule safeguards (164.312 technical safeguards), for compliance evidence.
Generates or ingests device SBOMs to track component CVEs across the medical device fleet, increasingly required by FDA and EU MDR for post-market security management.
Supports the documentation artifacts required by FDA cybersecurity pre-market guidance (threat model, SBOM, security architecture description, patch management plan), for device submission.
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