Medical Device

Copilot for FDA Cybersecurity

Smarter Vulnerability Decisions with an FDA-Approved Methodology

Meet ELTON

600+ FDA Regulatory Submissions.

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

Intelligent Product Security Backed by an FDA-approved Medical Device Development Tool (MDDT).

Meet ELTON

Architect

Intelligently creates a digital twin of a medical device by combining documentation, software telemetry, SBOMs, and runtime scanning to accurately model the product’s critical components, interfaces, and dataflows.

Collector

Aggregates vulnerability sources, including penetration testing, SAST, DAST, fuzzing, and SBOM CVEs, and then maps each finding to a component in the product’s architecture for contextual relevance.

Sentinel

Monitors for updates to known software and continuously adds new vulnerabilities to each release from multiple trusted sources. This ensures the vulnerability set remains current, allowing incremental addition and verification before any finding is used in exploitability or impact analysis.

Reviewer

Continuously re-scores all vulnerabilities as new vulnerabilities are identified or attack paths evolve, assigning updated ELTON CVSS scores that reflect point-in-time, product-specific exploitability and impact, ensuring accurate prioritization and always-on compliance.

Optimizer

Operates on the Architect digital twin and dynamic vulnerability ratings from Reviewer to enable simulation of potential fixes and pinpoint key vulnerabilities whose remediation can break attack chains or reduce the severity of higher-risk issues.

Drowning in vulnerabilities?

Regulators expect every vulnerability to be tracked and triaged indefinitely; doing so manually isn’t sustainable. ELTON Intelligence identifies what truly matters and pinpoints the smallest fixes that eliminate the highest risks. Clear priorities. Fewer patches. Maximum impact.

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of vulnerabilities have no exploitable path

%

of cyber patches can be avoided

%

reduction in post-market monitoring costs

%

better vulnerability decisions with ELTON

ELTON vulnerability identifier

Make Better Decisions with ELTON AI

Cut time and cost by automating vulnerability discovery, triage, and reporting, minimizing patch volume and compliance burden across every release.

Your Product Security Copilot

ELTON is an AI-driven platform with a fully transparent, FDA-Approved Methodology built for medical device cybersecurity. Through its Copilot interface, ELTON transforms complex technical data into clear, actionable insight, helping teams prioritize what truly matters and maintain compliance across the product lifecycle.

Global Compliance

Automate Vulnerability Metrics

Meet rigorous FDA regulatory vulnerability metrics across your entire product portfolio with ease, avoiding audit risks and generating defensible no-fix-needed evidence.

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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

ONE SOLUTION.

TOTAL COMPLIANCE.

The ELTON platform is designed specifically for medical device manufacturers. It combines expert intelligence with automation to deliver continuous penetration testing, SBOM analysis, SAST/DAST, and CVE management. Every platform product includes a digital twin of a commercial release, vulnerability identification, FDA-aligned reports, and real-time vulnerability monitoring across the entire product lifecycle, ensuring manufacturers maintain compliance and reduce long-term costs.

Meet ELTON

Intelligence is Compliance

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

ELTON digital twin of a medical device

AI for Medical Device Cybersecurity

Next-gen medical devices need next-gen solutions.

With ELTON AI, level up your compliance with an FDA-Approved approach and lower the total cost of cybersecurity.

Meet ELTON