About ELTON

We are the FDA Standard

The world’s only automated solution for medical device vulnerability compliance.

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

ELTON has submitted over 600 vulnerability reports to the FDA for approval. ELTON is the trusted tool built from a decade of real-world regulatory success.

AI-Powered Copilot analysis is regulatory defensible through ELTON’s use of the FDA-approved Rubric for Applying CVSS to Medical Devices

For manufacturers, ELTON streamlines premarket approvals, safeguards postmarket audits, and delivers continuous vulnerability metrics, ensuring portfolio-wide compliance at a fraction of the cost of full-time staff and manual spreadsheets.

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The FDA Vulnerability Experts

Simplifying Your Vulnerability Management Today

One platform for end-to-end vulnerability identification, insight, and surveillance.
Stay compliant without costly point solutions or a dedicated cybersecurity team for every product. ELTON is your copilot, enabling smarter, defensible vulnerability decisions at a fraction of the cost of a full-time cybersecurity team.

%

of vulnerabilities have no exploitable path

%

of vulnerabilities are overrated in severity

%

of ELTON ratings are FDA-compliant

Compliance Intelligence

Product Security with Intelligence

ELTON Copilot is built on insights and data from the field. View more insights

Case Study: Responding to FDA Addition Information (AI) Requests

Case Study

Background A late-stage medical device manufacturer faced a major regulatory setback after the FDA questioned their premarket cybersecurity submission. Their Software Bill of Materials (SBOM) listed nearly 100 unfixed vulnerabilities spanning embedded firmware, cloud...

Why Medical Device Manufacturers Must Validate Their Cybersecurity Tools

ELTON

Introduction In the medical device industry, every process and every tool used in design and development must meet rigorous quality standards. That includes not just testing equipment or software development tools—but also cybersecurity tools. Under FDA’s Quality...

Why FDA-Required Vulnerability Chaining – and How ELTON Delivers It

ELTON

Introduction In the medical device space, cybersecurity is no longer a check-the-box exercise. Connectivity, complex supply chains, and system interdependencies mean that a single vulnerability is seldom exploited alone. Instead, attackers typically exploit chains of...

A system architecture diagram showing components like Biosensor Device, Clinical Workstation, Android OS, PACS Server, Azure Container Instance, Central Database, and Workstation BMC, with connections between modules.

Intelligent Medical Device Cybersecurity

Transform how you manage vulnerabilities with ELTON, where FDA-approved methodology meets intelligent automation to deliver clarity, precision, and long-term efficiency across your entire product lifecycle.

Meet ELTON