Platform Capabilities
Cybersecurity Surveillance
ELTON provides continuous vulnerability surveillance in alignment with FDA requirements by monitoring your software ingredients (SBOM) for newly disclosed risks, assessing impact within your system, and prioritizing action based on an FDA-Approved Methodology.
Overview
X-Ray your Software and Analyze with AI
ELTON x-rays your product by combining SBOM generation with runtime insights to build a complete inventory of software ingredients.
It then enriches this list by mapping each component to its exact location within your product’s architecture, down to the specific software module or hardware interface it touches.
This attacker-oriented, relationship-based view focuses not just on whether a vulnerable function exists, but whether it’s exploitable in your system. If the component sits in an isolated or protected area, ELTON deprioritizes the risk, giving you clarity on what truly matters.
SBOMs: Frequently Incomplete, Often Misleading
Address Completeness
ELTON creates a complete digital twin where missing or inaccurate SBOM data becomes immediately visible. Digital twinning ensures that all high-risk components are not omitted from your SBOM for communication to the FDA and compliance with other submitted product documentation.
Employ Exploitability
Most SBOMs surface CVEs that aren’t exploitable in your specific release. ELTON automates exploitability analysis and enables manual verification to validate high or critical vulnerabilities before acting.
Avoid False Positives
ELTON replaces costly, error-prone stack tracing with a threat-actor-focused analysis, determining if a software component is truly exploitable and to what severity, reducing noise from low-impact SBOM vulnerabilities and defensibly pushing back on CVEs.
Automate Your Compliance with 2025 and 2016 FDA Regulations with ELTON Surveillance.
Make Sure They’re Rated Accurately
Your Product Will Inevitably Contain Hundreds of SBOM CVEs
ELTON fulfills FDA premarket and postmarket cybersecurity expectations by enriching SBOMs alongside other vulnerability sources, continuously monitoring for new CVEs, and determining if mitigation is required. It supports CAPA by documenting why unpatched SBOM issues are justified, ensuring manufacturers meet regulatory demands with defensible, risk-based analysis across all software components and product architectures. No SMEs required, fully automated.
Regulatory-Aligned Generation
ELTON generates a product-specific SBOM enriched with architectural and runtime data to fulfill 2025 FDA Premarket Cybersecurity Guidance expectations for Vulnerability Management SOPs. Each ingredient is linked to a component, interface, and trust boundary providing a defensible baseline to track, investigate, and justify vulnerabilities throughout the product lifecycle.
Exploitability-Based Monitoring
ELTON continuously monitors your SBOM against CVE databases and maps those findings to your product’s digital twin, fulfilling the 2016 FDA Postmarket Cybersecurity Guidance to assess whether a vulnerability truly requires remediation. ELTON highlights which issues are not exploitable based on architecture and defensibly deprioritizes.
Justifiable CAPA and Audit Readiness
With ELTON, unresolved SBOM findings are not an ignored audit timebox, they’re contextualized, rated, and documented using the FDA-approved Rubric for Applying CVSS to Medical Devices. This fulfills CAPA obligations by ensuring every issue has a traceable justification, even if left unpatched.
Avoid Audit Issues and Starting Properly Rating All Your SBOM Vulnerability Data.
Preempt SBOM CVE Debt
Preempt the thousands of CVEs each product release can generate before they accumulate into unmanageable technical debt. ELTON filters noise, prioritizes real risk, and prevents costly, unnecessary remediation work.
Advisories
We Track Down Zero-Day CVEs
Our cybersecurity researchers have identified and disclosed multiple zero-day Common Vulnerabilities and Exposures (CVEs) in networks, devices, and related software.
Verizon MiFi Invalidated CSRF Token for File Uploads
Impact: High
HtmlImport Unauthenticated Remote Code Execution
Impact: High
Compliance Insights
Power Your Postmarket Maintenance with Intelligence
ELTON Copilot is built on insights and data from the field. View more insights
Lowest Cost of Cybersecurity Maintenance.
ELTON delivers better vulnerability monitoring through context and defensibility with an FDA-Approved approach.