ELTON is a subscription that automates medical device cybersecurity testing, determines exploitability, and tracks remediation and FDA evidence on every release.
Trusted by 6 of the top 10 medical device manufacturers, ELTON protects over $1 trillion in market cap
ELTON digital twins your product's security architecture and tests from your lab or ours.
Every finding is triaged for exploitability, so you disposition less.
Reachable on its own from the device's exposed attack surface. This is what earns the name vulnerability, and it goes to a developer now.
Reachable only through indirect access, when another vulnerability breaks first. Mapped to its root and watched, because fixing the root turns it inert.
No exploit path on this device today. Documented with the reasoning attached, and not called a vulnerability, because it is not one.
The pipeline does the expensive part. The subscription covers what a consultancy meters.
Basis of claim: median time-to-findings of 4 weeks and a cost of approximately $100,000 for a consulting pentest, verified across 3 medical device cybersecurity consulting firms. ELTON delivers findings inside 2 days on covered devices.
FDA wants traceability, teams want speed. Consultants deliver neither.
ELTON surfaces vulnerabilities faster than any consulting firm can start, runs on-demand, every build, no surprises.
A consultant sells you a snapshot. ELTON tests all year on one subscription. Same evidence FDA expects, at a quarter of the spend.
Consulting shops say something is wrong, not how to fix it. ELTON ships prescriptive remediation down to the code.
Prescriptive fixes for the exact line, delivered where your developers already work. Open a ticket, or run it closed-loop over ELTON MCP.
Every cybersecurity deficiency traces back to human mistakes or a consulting budget that ran out. Point-in-time testing and a lack of exploitability management risk your entire submission. ELTON prevents this by doing it right, continuously, from the beginning.
Interfaces and components shipped without evidenced testing.
No documented test cases mapped to threats and interfaces.
No prior results, and no plan to keep testing.
No defensible reason a finding was not fixed.
No test case or retest evidence behind the mitigation.
SBOM and scanner findings never proven exploitable on the live product.
AI-native vulnerability testing is outgrowing management, and the FDA questions everything you didn't fix.
Premarket and postmarket regular testing and management of every vulnerability.
AI vulnerability discovery is here. Your spreadsheets won’t keep up. ELTON finds and manages.
Senior engineers burn quarters proving CVEs don't apply to your device. That work ships nothing.
But every dismissal needs evidence. FDA reviewers probe the findings you didn't fix, not the ones you did.
Today an engineer re-rates every finding by hand, weeks of work, stale at release. ELTON tracks each one on the twin, classified, mitigation attached. No spreadsheets.
Reachable and exploitable on the release as shipped. Rated against the product, not the worst case, and queued for a fix.
Real, but only once another exploit or an external condition opens the path. Tracked with the condition named, not guessed.
No path from any entry vector on this release. Severity neutralized by design, with the rationale recorded for the audit.
FDA will ask for all seven. Can you produce them today?
A managed program: our team runs discovery and verification continuously. Your teams get the platform, and a TestLink™ appliance on the bench.
Submission-ready SBOM and VEX exports, generated from the twin and the testing record. Not assembled by hand.
Tell us the device and the workload. We show you the graph: the handful to fix, and the evidence for everything else.
Triage that never touches the device is guessing. ELTON reaches a physical unit three ways: our lab, a remote session into yours, or TestLink™ on your bench over out-of-band 5G.
Every TestLink™ is a pentester in a box, run from one console over out-of-band 5G. Watch the fleet live: connections, sessions, latency. One bench to a deployment grid, no lab.
Built by the team behind 1,000+ FDA submissions. Trusted by 6 of the top 10 medical device manufacturers.
“The vulnerabilities reported to us today by third parties are AI slop. ELTON helps us automate why they don't matter, it's the only method that has held up to FDA audit.”
“We have done many FDA submissions with ELTON's data and had not a single deficiency, we test early and often with AI.”
“We use ELTON's subscription testing services and it has changed how our organization views cybersecurity testing, it's flexible, fast, and better.”
“We swapped an annual pentest for continuous coverage. Findings land while the release is still open, not months later.”
“Our regulatory team stopped assembling evidence by hand. The VEX and rationale come out of the platform ready to submit.”
“ELTON showed us the ten findings out of thousands that mattered, and proved the rest. That is the whole job.”
“The vulnerabilities reported to us today by third parties are AI slop. ELTON helps us automate why they don't matter, it's the only method that has held up to FDA audit.”
“We have done many FDA submissions with ELTON's data and had not a single deficiency, we test early and often with AI.”
“We use ELTON's subscription testing services and it has changed how our organization views cybersecurity testing, it's flexible, fast, and better.”
“We swapped an annual pentest for continuous coverage. Findings land while the release is still open, not months later.”
“Our regulatory team stopped assembling evidence by hand. The VEX and rationale come out of the platform ready to submit.”
“ELTON showed us the ten findings out of thousands that mattered, and proved the rest. That is the whole job.”
One issue a month on AI, exploitability, and FDA cybersecurity review. Read by product security and regulatory teams at 6 of the top 10 manufacturers.
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.
It is the practice of deciding which of your known vulnerabilities can actually be exploited on the product as shipped, and evidencing that decision. A CVE in a component is not automatically a risk to your device. Exploitability management establishes whether an attacker can reach it, whether the preconditions hold in your configuration, and what evidence supports the answer either way.
Most vulnerabilities in a device's software bill of materials are not reachable on that device. They sit in code paths that are never executed, behind controls that break the attack path, or on interfaces the product does not expose. ELTON tests reachability against the real product, so the small number that are genuinely exploitable get fixed and the rest get a documented reason they do not.
Yes, but not on assertion alone. A reviewer expects the reasoning behind a dismissal: which attack path was considered, what blocks it, and what testing supports that. ELTON produces that record as a byproduct of testing, which is the difference between saying a finding does not apply and being able to show it.
A scanner never touches your product. It matches component versions against a CVE database and reports what could theoretically be present, which is why its output needs triage before anyone can act on it. ELTON runs against the real device and answers whether the exploit works there.
As a fixed annual subscription rather than per engagement. ELTON ONE covers a single product model for twelve months including premarket and postmarket. ELTON ENTERPRISE is priced on continuous testing capacity across a business unit or portfolio.