Automate vulnerability identification and triage with advanced exploitability analysis, reducing patch volume while lowering cost and compliance burden across every product release.

Your Vulnerability Copilot

ELTON is a medical device cybersecurity platform that ties vulnerability testing, SBOM analysis, threat modeling, and ongoing monitoring directly back to product architecture and design controls, producing defensible, product adjusted risk ratings aligned to global regulatory expectations. With a fully transparent, FDA-Approved Methodology ELTON transforms complex testing results into clear, actionable insight, helping teams prioritize what truly matters and maintain compliance across the product portfolio.

Avoid Regulatory Troubles

Automated Analysis

Meet rigorous regulatory Vulnerability Metrics across your entire product portfolio and generate defensible evidence of testing and remediation.

Time-to-Triage

Vulnerability Density

Time-to-Remediation

Patch Adoption Rate

Frequency of Testing

Disclosure Timeline

Traceability.

Completeness.

Defensibility.

ELTON provides full traceability and completeness across vulnerability testing and analysis by anchoring both test cases and findings to a specific product architecture, release, and execution context through its digital twin. Every vulnerability is traceable through testing, analysis, decision, and disposition, including clear justification for fix or no fix decisions aligned to regulatory expectations.

Meet ELTON

Intelligence is Compliance

ELTON is powered by insights from over a decade of medical device testing expertise and 600+ FDA-approved testing submissions. View More Insight

“We Did a Pentest” No Longer Satisfies Medical Device Regulators

Compliance and Regulation

Introduction For more than a decade, we have had a singular focus on cybersecurity testing of medical device targets. During this time, our teams have executed thousands of medical device security assessments, including more than 600 penetration tests that directly...

Understanding Is Predictability: A Better Model for Vulnerability Management

ELTON

The question is no longer, “Do you know every vulnerability in your product?” It is, “If one appeared tomorrow in this part of the system, do you already know how it would be rated—and can you defend why?” If the answer is no, vulnerability management is still...

QMSR: FDA Replaced 21 CFR Part 820 with ISO 13485:2016 – What does this mean for cybersecurity?

Compliance and Regulation

This week marks a significant milestone in medical device regulation. The FDA's Quality Management System Regulation (QMSR) officially took effect on February 2, 2026, replacing the longstanding 21 CFR Part 820 Quality System Regulation (QSR). This harmonization...

Abstract digital illustration of a brain outlined with glowing, interconnected purple lines and nodes on a dark background, symbolizing AI or neural networks—ideal for concepts like FDA vulnerability management or advanced cybersecurity solutions.

Next-Gen Products Need Next-Gen Solutions.

With ELTON, level up your compliance and lower the total cost of cybersecurity.

Meet ELTON