Better Ratings. Less Patching.
Intelligent
Posture Management
Total FDA Vulnerability Compliance
1 Year. 1 Fee. Total Compliance
Vulnerabilities aren’t fixed—they’re made unexploitable or unreachable.
Lower the lifetime cost of cybersecurity maintenance.
Discover
ELTON creates a digital twin of a medical device by combining software, firmware, and system architecture data from SBOMs, source code, and real-time scanning to accurately model the product’s components, interfaces, and dataflows.
Identify
ELTON identifies vulnerabilities by aggregating results from SBOM analysis, SAST, DAST, fuzzing, and manual penetration testing, then mapping each finding to the product’s architecture for contextual relevance.
Contextualize
ELTON contextualizes each vulnerability by analyzing its location within the product’s architecture, connected components, access paths, and built-in mitigations to determine real-world exploitability and impact.
Monitor
ELTON continuously intakes new vulnerabilities and re-assesses all existing ones in real time, resulting in living vulnerability management that enables teams to focus on what matters today—not what mattered yesterday.
Optimize
ELTON’s digital twin and living vulnerability data enable simulation of potential fixes and pinpoint the key issues whose remediation can break attack chains or reduce the severity of higher-risk vulnerabilities.
Drowning in vulnerabilities? You’re not alone.
Every SBOM update, every new release, and every SAST/DAST/Pentest adds to the pile. Regulatory bodies expect you to triage and track each one—forever. It’s unsustainable. ELTON turns the chaos into clarity, automating the grind and exposing what really matters and the simplest fix to address them all. Fewer patches. Less noise. Zero audit panic.
Full-time Cyber Engineer Per Product
Sources of vulnerability data (SBOM, SAST, DAST, fuzzing, and pentesting)
Unique vulnerabilities per release
Vulnerabilities by year two
%
Of Manufacturers must meet FDA metrics
Avoid unnecessary patches with ELTON
Save time and cost by automating vulnerability discovery, triage, and reporting reducing patch volume and compliance overhead across every product release.
Premarket Services
Start strong. Stay compliant.
For new products, the FDA expects a comprehensive Vulnerability Management SOP as part of your premarket submission—a commitment that extends across the product lifecycle. ELTON helps you meet all premarket cybersecurity testing and vulnerability management requirements while seamlessly preparing you for postmarket management.
Know How
Expert Regulatory Insights
ELTON automates global post-market vulnerability compliance so you don’t need to master every regulation, region, or requirement to stay ahead.
Global Compliance
Pass Audits with Automated Vulnerability Metrics
Meet rigorous FDA regulatory vulnerability metrics across your entire product portfolio with ease, avoiding audit risks and generating defensible no-fix-needed evidence.
Since 2014 600+ Penetration Tested Approved by the FDA
ELTON Subscription Services
ELTON offers subscription-based cybersecurity testing and vulnerability management services tailored for medical device manufacturers. With expert support and automation at its core, ELTON also delivers continuous penetration testing, SBOM analysis, SAST/DAST, and CVE triage—backed by FDA-aligned reports and real-time monitoring across the product lifecycle.
For 10+ years, we’ve helped medical device manufacturers protect their products.
Protecting Medical Devices Is Our Mission
Next-gen medical devices need next-gen solutions.
Elton simplifies risk and regulatory management, unlocking more AI, cloud connectivity, innovation, cost savings, and reach.
For manufacturers, it’s more efficiency. For patients, it’s more health, privacy, and time with loved ones. Healthier, happier, longer lives start here.