Drowning in vulnerability reports?
One Platform. Total Compliance.
Streamline FDA vulnerability compliance with a pre-validated solution.
Overview
Your Vulnerability Copilot
ELTON is a pre-validated medical device vulnerability platform built on more than a decade of hands-on testing experience with the FDA. The platform delivers every FDA-required testing activity with validated output. Using a digital twin, attack path analysis, vulnerability chaining, and remediation optimization, ELTON delivers precise, context-aware results that reflect real-world exploitability. Through its Copilot interface, ELTON transforms complex vulnerabilities into clear, actionable insight, helping teams focus on the vulnerabilities that truly matter.
ELTON enriches vulnerability data to ensure the best decision-making, with output that maintains full traceability and defensibility due to an FDA-Approved Medical Device Design Tool and CVSS Vulnerability Rating Rubric
Premarket + Postmarket
ELTON ONE
1 Year. 1 Fee. No Additional Tools. Total Compliance.
LTON ONE is a subscription platform that fulfills all FDA vulnerability compliance requirements through a product-as-code model. It enables precise vulnerability mapping and contextual CVSS scoring tailored to each product’s unique architecture. Continuous CVE monitoring tracks changes in the threat landscape, providing on-demand visibility, posture management, and regulatory reporting across every product release.
Platform Capabilities
ELTON platform is an integrated vulnerability testing service to deliver traceable, defensible results across a variety of vulnerability sources.
Discover
Context Matters. ELTON first creates a digital twin to transform target architecture and security control data into a graph for actionable intelligence.
Identify
ELTON executes testing. Effective triage links pen testing, SAST/DAST, SBOM CVEs, real-time risk, and machine-readable vulnerability data.
Contextualize
ELTON adjusted ratings by mapping findings to architecture, adjusting for context, correlating sources, and evaluating chained exploitability across components.
Monitor
ELTON continuously monitors materials, integrates test results, and adjusts vulnerability ratings in response to new vulnerabilities or posture context.
Optimize
Perform ‘what if’ analyses to identify packages of vulnerabilities to remediate, and if fixed, their impact on overall posture for better decision-making.
Compliance Requirements
ELTON streamlines vulnerability compliance by automating discovery, triage, and testing for better, more informed results.
FDA Premarket Requirements
ELTON fulfills premarket vulnerability testing requirements, ensuring accurate, defensible vulnerability ratings aligned with documentation and regulatory expectations.
Secure Product Development Framework
ELTON operationalizes a SPDF by integrating vulnerability data with security design, threat modeling, and vulnerability management during development.
FDA Postmarket Requirements
ELTON meets FDA postmarket guidance by automating continuous vulnerability identification, triage, threshold alerts, and metric collection across product lifecycles.
Total Product Lifecycle Management
ELTON delivers a unified view to manage vulnerability compliance across every product, model, and release—ensuring coverage through end-of-life.
Patch Optimization & No-Fix Defensibility
Identify high-impact fixes and generate evidence showing vulnerabilities are unexploitable or unreachable enabling compliance without unnecessary patching.
Exploitability Analysis
Drowning in a vendor vulnerability report?
ELTON maps complete attack paths between exposed attack surfaces and destination vulnerabilities, traversing discovered components, dataflows, and architectural boundaries. By simulating how attackers would move through the system, ELTON identifies whether a vulnerability is not just reachable, but truly exploitable with actional intelligence for how to mitigate. ELTON’s output is fully FDA compliant, defensible, and traceable for Corrective and Preventative Actions.
FDA-Compliant
Virtual Patching
ELTON’s exploitability-based approach enables fully automated triage by analyzing each vulnerability in the context of real attack paths, system architecture, and built-in mitigations. Once set up, each commercial release self-triages its vulnerabilities daily producing lower, more accurate severity ratings for issues that are not actually exploitable.
The Future is
Pentest-as-Code
Product-as-code is the future standard for expressing product architecture and cybersecurity posture to regulators and customers. It enables accurate vulnerability analysis and risk evaluation especially critical in the AI era. ELTON creates product-as-coded out of every product, model, and release to ensure a proper cybersecurity view and on-going posture management. Vulnerability findings can be overlayed on a Product-as-Code for an extensible reporting output.
Compliance Insights
Intelligent Product Security
ELTON Copilot is built on insights and data from the field. View more insights
No Additional Tools. One Smart Solution.
ELTON reduces cost by including all testing needs, eliminating unnecessary patching, and automating the most resource-intensive vulnerability management tasks. Achieve full compliance without expanding headcount.