If it's not exploitable, it's not a vulnerability. Most security programs run on probability: severity scores, reachability guesses, arguments in a triage meeting. ELTON runs on proof. A finding counts when the exploit has executed on the real device and the evidence is attached to the verdict.
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. Unscalable in the AI era.
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.
A verified ELTON finding is not a row in a spreadsheet. It is a package a reviewer can replay: the test case that ran, the execution log it produced, the observed result, and the VEX status that follows. Dismissals carry the same package, because not affected is a claim that needs proof too.
Each verdict also answers the questions SSVC actually asks. Is the attack automatable? Does it end in total compromise of the device? Which vectors reach the flaw? Is there a working proof of concept? Grounded in an executed test, those four answers turn a score into a decision you can defend.
Proof is the foundation the rest of the platform stands on. It is how ELTON can find the 1% that matter, why an FDA-qualified rating methodology holds up in review, and what separates the pipeline from a prompt. The mechanics live on the verification page.
Every CVSS 4.0 decision is computed from the device’s documented architecture. Same inputs, same score, every run. This is the full path a rating takes, and every stop on it is traceable.
ELTON starts from documentation you already produce for FDA review: architecture views and data flow diagrams, SBOM, threat model, risk management report, security controls, and cybersecurity testing reports. No new paperwork, no questionnaires.
The documentation becomes a machine-readable graph. Components become nodes carrying trust level, assets with CIA sensitivity, countermeasures, and deployment configurability. Data flows become directed edges typed Network, Adjacent, Local, or Physical. Every element is tagged to the document it came from, and every manual edit is logged.
Each finding attaches to the exact component it lives on, whether it arrives from a pentest report, an SBOM scan, the public CVE feed, or a user entry. The vulnerability carries SSVC context and an on-component exposure indicator before any path analysis begins. The unit of analysis is always one vulnerability on one component in one device design.
For each initial access point in the threat model (Wi-Fi, Bluetooth, USB, the user interface, a debug port), ELTON derives the feasible paths an attacker can take to reach the component and the propagation paths after compromise. Traversal respects trust boundaries and directionality, so infeasible paths never inflate a score. Each entry point is scored as its own scenario.
Each metric is computed by rules that extend the FDA-qualified rubric (Q171974) to v4.0. Exploitability metrics read the entry interface, trust levels traversed, countermeasures, configurability, and user interaction. Impact metrics read asset sensitivity on the vulnerable component and everything downstream. If no feasible path exists, the scenario is marked non-exploitable. No questionnaires, no judgment calls.
Every entry point gets a complete vector, score, and metric-level justification naming the components, interfaces, trust levels, and assets that drove it, cited back to your submission documents. The canonical score is the highest-severity feasible scenario; the others are retained as context. Change the architecture and the score changes with it. Nothing else moves it.
A v3.1 vector cannot be mechanically converted. The new metrics need information a score alone does not carry. The twin and the dependency graph supply it.
Network segmentation, required pairing, physical access assumptions: the digital twin already holds the deployment conditions AT asks about.
The dependency graph knows which findings produce the conditions others require, so subsequent system scores reflect real chains, not guesses.
Every finding carries both scores during the transition. Submissions already in flight stay consistent while new work adopts v4. Nothing gets re-rated by hand on a deadline.
The same evidence carries the submission, the rating, and the postmarket record.
What FDA expects from cybersecurity testing, and where executed evidence fits in a submission.
The FDA-qualified rubric that turns verified exploitability into a rating a reviewer accepts.
Why a point-in-time test cannot produce proof for a product that ships releases all year.
Bring one device. We build the twin, run discovery, and hand you a verified finding with its executed test case, log, and VEX status. Then a dismissal with the same.
Proof over probability means a finding only counts once the exploit has executed on the real device and the evidence is attached to the verdict. The rule cuts both ways. Not exploitable means the executed test that failed and the reason it failed, so the evidence exists before the verdict does.
A CVSS 9.8 describes the worst case deployment of a component, not your device. It predicts, it does not demonstrate. A number pulled from a national database cannot say whether the path is reachable on your build, which is the question both an engineer and a reviewer need answered before anyone spends a sprint on it.
Dismissals carry the same package as confirmed findings, because not affected is a claim that needs proof too. The record holds the test case that ran, the execution log it produced, the observed result, and the VEX status that follows. A reviewer can replay it rather than take the disposition on trust.
Nothing ships on an agent's opinion. Agents explore, chaining protocols and abusing assumptions the way a researcher would, and exploration is allowed to be wrong. A finding graduates only when deterministic logic executes the exploit against the real target and the result reproduces. Creativity proposes, determinism decides.
A verified finding answers the questions SSVC actually asks. Is the attack automatable, does it end in total compromise of the device, which vectors reach the flaw, and does a working proof of concept exist. Grounded in an executed test, those four answers turn a score into a decision you can defend.