Why Medical Device Manufacturers Are Choosing ELTON for Vulnerability Management

A New Era of Cybersecurity Oversight

Cybersecurity for medical devices has entered a new era—one where continuous oversight is not only best practice but a regulatory requirement. The FDA’s June 2025 guidance makes it clear: manufacturers must establish and maintain processes to monitor, identify, and address vulnerabilities across the full product lifecycle. This mandate applies to both new releases and legacy devices still in active use. The challenge for manufacturers is straightforward but significant: how can you maintain visibility and manage risk without slowing development or overwhelming internal teams?

ELTON was designed for this exact problem. Our platform delivers continuous, product-aware vulnerability management with real-time updates, advanced contextual scoring, and automated postmarket compliance reporting. By integrating directly into your lifecycle processes, ELTON ensures security and regulatory teams have a dynamic, transparent view of each product’s security posture—without creating unnecessary overhead for engineering.

Static Reports Are Out. Living Intelligence Is In.

Traditional cybersecurity assessments rely on static reports that capture only a moment-in-time snapshot. These documents quickly become outdated as new CVEs emerge, software libraries evolve, and devices are reconfigured. By the time regulators or auditors request evidence, teams often face a scramble to reconcile stale reports with current risk.

ELTON replaces static reporting with living vulnerability intelligence. Our system continuously ingests public CVE feeds, incorporates SBOM monitoring, and updates findings in real time. Every vulnerability is re-scored based on the current architecture and deployment context. Penetration test results, SBOM analysis, SAST/DAST outputs, and device usage insights are merged into one auditable record. Teams no longer need to chase updates manually—ELTON ensures every product release always has an accurate and traceable vulnerability profile.

Smarter, Defensible Scoring Through Context

Generic vulnerability ratings often mislead manufacturers. A HIGH-severity flaw in one product may be unexploitable in another due to privilege requirements, access controls, or architecture. Without context, teams waste resources chasing issues that do not reduce real risk.

ELTON changes this by applying system-specific context to every vulnerability. Using digital twin modeling, ELTON maps how components interact, what trust zones are crossed, and where mitigations already exist. Vulnerabilities are scored using CVSSv4, enhanced with automated computation of complex metrics like Attack Requirements. The platform further evaluates chained vulnerabilities—showing how LOW-severity issues can enable escalation to HIGH or CRITICAL levels. This ensures manufacturers focus remediation on changes that truly improve security, while avoiding unnecessary patching.

Portfolio-Wide Oversight at Scale

Managing vulnerabilities across a portfolio of devices, versions, and configurations is one of the hardest challenges for medical device cybersecurity. ELTON addresses this by providing a centralized, portfolio-wide system of record.

Manufacturers can view and triage vulnerabilities by product, release, or component, and identify common weaknesses across devices. This portfolio view makes it possible to detect systemic risks, streamline remediation, and enforce consistent policy across business units. ELTON’s “product-as-code” models include digital representations of every product’s architecture, interfaces, and controls. These models allow for impact analysis, side-by-side comparisons, and visualization of dataflows—making it easier to understand and respond to changes at scale.

Meeting FDA Expectations Without the Bottleneck

The FDA’s 2025 guidance expects manufacturers to demonstrate continuous monitoring and proactive risk management. Periodic penetration testing, SBOM monitoring, vulnerability triage, and audit-ready documentation are all mandatory elements of compliance.

ELTON delivers these capabilities out of the box. Vulnerabilities are continuously re-evaluated as new threats surface, with full traceability of scoring changes and remediation actions. Historical records are preserved for audit defense, while dashboards and automated reports simplify communication with regulators and internal stakeholders. Importantly, ELTON reduces operational burden by optimizing remediation strategies. Instead of blindly fixing every HIGH-severity finding, the system highlights root causes and remediation points earlier in attack paths, often through smaller, more effective changes.

Built for Compliance. Designed for Efficiency.

Regulators, auditors, and customers expect manufacturers to demonstrate not only secure design but also sustained, transparent oversight. ELTON ensures that compliance evidence is always current and defensible. Metrics such as vulnerability density, time-to-triage, and penetration test coverage are tracked automatically. Vulnerability profiles are maintained separately for each commercial release, ensuring postmarket compliance is demonstrable at any point in time.

With ELTON, manufacturers achieve safer products, stronger regulatory alignment, and reduced operational burden. Instead of reacting to FDA findings or struggling to unify disparate data sources, teams gain confidence in their ability to continuously protect their devices and their patients.