Copilot for Medical Device Cybersecurity
Streamlined Premarket Approvals.
Continuous Postmarket Protection.
Request a Platform Walkthrough
Built for the Next Generation of MedTech and AI-Enabled Devices
Copilot for Medical Device Cybersecurity
Streamlined Premarket Approvals.
Continuous Postmarket Protection.
Request a Platform Walkthrough
Built for the Next Generation of MedTech and AI-Enabled Devices
Over 1,000 FDA 510k and PMA submissions
Trusted by 6 of the World’s Top 10 Manufacturers.
Globally Compliant
ISO 14971 UL 2900 AAMI TIR57 AAMI TIR97 IEC 62304 ISO 13485 ISO 27001 IEC 81001-5-1 IEC 62443-4-1
Pre-Approved
Backed by an FDA-Approved Medical Device Development Tool (MDDT) for defensible vulnerability reports, without pushback.
Quality Validated
Pre-validated for use inside a manufacturer’s ISO 13485-compliant QMS as a software tool for cybersecurity.
New Vulnerabilities Reported Annually
%
Require Regulatory Review
%
Meaningfully Impact Safety
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ELTON AI Identifies Vulnerabilities That Matter
Support vulnerability decisions with a traceable, FDA-approved solution.
Intelligent Postmarket Monitoring
Automate vulnerability identification and triage with advanced exploitability analysis, reducing patch volume while lowering cost.
MedTech Cybersecurity Copilot
ELTON is a cybersecurity platform purpose-built for complex AI-enabled medical devices. It connects vulnerabilities across the entire AI lifecycle, including data pipelines, model assets, software components, and deployment environments, directly to system architecture and design controls.
Using a fully transparent, FDA-Approved Methodology, ELTON produces results that meet the FDA Artificial Intelligence-Enabled Device Software Guidance with defensible, product-adjusted risk ratings aligned to global regulatory expectations. Complex AI and software vulnerabilities are transformed into clear, architecture-aware, regulatory-ready decisions.
Eliminate Regulatory Risk
Medical Devices Demand Defensible Cybersecurity
Meet rigorous cybersecurity and Vulnerability Metrics across your entire product and AI lifecycle, from data pipelines and model development to deployment and updates, and generate defensible evidence of testing, risk decisions, and remediation without spreadsheets.
Traceability.
Completeness.
FDA Defensibility.
ELTON utilized an FDA-Approved Medical Device Development Tool (MDDT) designed to support vulnerability management across the medical device lifecycle. With end-to-end traceability from system architecture and components through vulnerability identification, triage, and remediation.
Where Industry Expertise Meets AI Automation
ELTON is powered by insights from over a decade of medical device testing expertise and 1000+ FDA-approved submissions. View FDA Cybersecurity Guidance
Next-Gen Products Require Next-Gen Solutions.
With ELTON, level up your compliance and lower the total cost of cybersecurity.