Company

Built by the people who have been hacking medical devices for a decade.

ELTON is a medical device cybersecurity company. We solve the vulnerability avalanche. The platform is built on more than a decade of hands-on device testing and hundreds of FDA-reviewed submissions, productized as a continuous AI testing pipeline.

The objective, in numbers

Find the 1% that require fixing. Evidence why the other 99% don't.

1%
Genuinely require fixing
ELTON isolates them
99%
Dismissed with reasoning
Captured as a regulatory-ready artifact
600+
FDA submissions
Behind the team and methodology
6 of 10
Top device makers
Trust ELTON
The FDA vulnerability experts

One platform for end-to-end vulnerability management.

Trusted by 6 of the world's top 10 manufacturers and hundreds of emerging device makers. ELTON has taken more than 600 vulnerability reports through FDA review, and wrote the methodology that many successful submissions rely on.

A decade of device hacking

Exclusively focused on medical devices since 2013. The offering encodes that expertise as test-case-based testing: SAST, DAST, fuzzing, and pentesting.

FDA-recognized methodology

Backed by an FDA-approved Medical Device Development Tool for defensible vulnerability reports, pre-validated for use inside an ISO 13485 QMS.

Vulnerability research

ELTON researchers have disclosed zero-day CVEs across devices and connected products, from infusion-adjacent systems to network hardware. That research informs ELTON AI.

Get started

See your device through ELTON.

Start with one device. We build the twin from documentation your quality system already produces, run AI discovery remotely, and show you the graph: the handful to fix, and the evidence for everything else.

Automate medical device vulnerability discovery and verification. FDA §524B methodologyExploitability proven on-device95% faster than legacy testing Book a Demo
Platform
Platform OverviewDigital TwinAutonomous TestingExploitability VerificationVulnerability GraphRemediation OptimizationELTON TestLink™Lifecycle & MetricsCVSSv4 Migration
Solutions
FDA §524BEU MDR/CRAEU REDNIS2IMDRF N60 / N73Postmarket SurveillanceIncident Response
Why ELTON
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