About ELTON
#1 Medical Device Cybersecurity Solution
ELTON is the largest medical device cybersecurity testing firm in the world.
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.
- FDA-Approved Medical Device Tool
- Streamlined Regulatory PMA/510K Approval
- 600+ Medical Devices Approved with ELTON
- Audit-Ready Postmarket Monitoring
- FDA-Approved Methodology for Vulnerability Rating
- FDA-Compliant Vulnerability Metrics
- CVSSv4 2027 Deadline Ready
- 2026 QSMR IOS 13585 Compliant
- Pre-Validated and Approved ISO13585 Cybersecurity Tool
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
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.