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 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.
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 device pentesting across thousands of devices and hundreds of regulatory submissions. The people who ran that testing built the harness, so the tradecraft runs as software rather than as billable hours.
Enterprise pentest platforms are built to find novel vulnerabilities in web applications. Medical device manufacturers have a different problem: known CVEs landing on their SBOM every week, each one owing the FDA an answer. ELTON maps those known CVEs to your specific device and produces evidence a reviewer will accept, including VEX and MDDT CVSS.
ELTON is trusted by 6 of the top 10 device makers and stands behind 1,000+ FDA submissions, with 1,000+ devices tested and cleared. The team has worked exclusively on medical devices since 2013, from hardware through cloud. Findings arrive inside the release cycle, 95% faster than legacy testing.
ELTON builds the digital twin from documentation your quality system already produces, so there is no new paperwork and no questionnaire. Discovery then runs remotely against that twin, and you get the graph back: the handful of findings that require fixing, and the evidence for everything else. Most programs start with a single device.
ELTON runs incident response against the twin instead of starting a new engagement, because the device context is already loaded. The commitment is verification in 4 hours, early warning in 24 hours, and a full report in 72 hours. Legacy pentest and vulnerability management tools offer no equivalent.