ELTON AI is not an AI wrapper. It is a custom harness and testing pipeline built by medical device experts, encoding a decade of manual physical device pentesting across thousands of devices and hundreds of regulatory submissions.
Exploitability is demonstrated on the real device, not asserted from a diagram. Regulators accept evidence, not opinion.
ELTON's CVSS methodology uses the FDA-qualified Rubric for Applying CVSS to Medical Devices. Give the same CVE to ten people and you get ten ratings. ELTON gives one, contextualized and defensible.
Every assessment enriches the twin. Agents start with full architecture and SBOM pre-loaded, so there is zero recon time and context grows with every release.
Developers ignore theory and act on proof. ELTON sends verdicts with PoCs, not a queue of maybes.
Exclusively focused on medical devices since 2013. The scope spans hardware to cloud, and every decision is evidenced for regulatory review.
524B, CRA, and NIS2 are ongoing obligations. ELTON ingests CVEs, re-triages, and tracks lifecycle every day, not once a year.
Enterprise pentest platforms find novel vulnerabilities in web apps. Medical device manufacturers are buried under known CVEs hitting their SBOM every week, and owe the FDA evidence for every one.
| Dimension | Legacy pentest and VM tools | ELTON |
|---|---|---|
| What it finds | Novel vulns in web / software | Known CVEs mapped to your specific device |
| Proof standard | Exploit for a security team | Evidence the FDA will accept (VEX, MDDT CVSS) |
| Cadence | Point-in-time engagements | Continuous postmarket surveillance |
| Regulatory standing | None | FDA-recognized MDDT methodology |
| Incident response | None | 4hr verify · 24hr early warning · 72hr full report |
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.