1% of Vulnerabilities Actually Matter

Automate Analysis Regulators Expect

Meet ELTON

600+ FDA Submissions

Trusted by 6 of the World’s Top 10 Manufacturers.

The #1 Medical Device Cybersecurity Testing Company Backed by an FDA-Approved Vulnerability Analysis Process

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Trusted

Trusted by 6 of the world’s top 10 medical device manufacturers and referenced in over 600 FDA submissions.

Compliant

Backed by an FDA-approved Medical Device Development Tool (MDDT) for defensible vulnerability results.

Validated

Pre-validated for use inside a manufacturer’s ISO 13485-compliant QMS as a software tool for cybersecurity.

Drowning in Vulnerabilities?

Regulators expect every vulnerability to be tracked and justified.

Traditional approaches are inefficient and difficult to defend.

New Vulnerabilities Released in 2025

%

Must be Triaged by Manufacturers

%

Actually Exploitable in Your Product

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Lowest Cost of Vulnerability Ownership

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.

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Time-to-Triage

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Vulnerability Density

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Time-to-Remediation

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Patch Adoption Rate

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Frequency of Testing

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Disclosure Timeline

FDA Building

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

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Next-Gen Products Need Next-Gen Solutions.

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

Meet ELTON