Medical Devices Require Unique Solutions.
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?
Regulatory bodies expect you to triage and track each one, forever. It’s unsustainable. ELTON identifies what truly matters and pinpoints the simplest fixes that address the greatest risks. Fewer patches. Clear priorities.
%
of vulnerabilities have no exploitable path
%
of cyber patches can be avoided
%
reduction in post-market monitoring costs
%
better vulnerability decisions with ELTON
Avoid unnecessary patches with ELTON
Cut time and cost by automating vulnerability discovery, triage, and reporting—minimizing patch volume and compliance burden across every release.
Premarket & Postmarket Vulnerability Management
Start strong. Stay compliant.
For new products, the FDA requires a comprehensive Vulnerability Management SOP within the premarket submission, with obligations that continue throughout the product lifecycle. ELTON ensures full coverage of premarket cybersecurity testing and vulnerability management requirements and transitions seamlessly into postmarket oversight.
Know How
Avoid Audit Findings
ELTON unifies global postmarket vulnerability compliance, enabling manufacturers to stay ahead without needing to navigate every regional regulation or requirement in detail.
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+ Products Tested by ELTON and Approved by the FDA
ELTON ONE Services
ELTON ONE is a subscription-based cybersecurity testing and vulnerability management service designed specifically for medical device manufacturers. It combines expert support with automation to deliver continuous penetration testing, SBOM analysis, SAST/DAST, and CVE triage. Every subscription includes vulnerability identification, FDA-aligned reports, and real-time vulnerability monitoring across the entire product lifecycle, ensuring manufacturers maintain compliance and reduce long-term costs.
For more than a decade, we have supported medical device manufacturers in securing their products with approaches that are both effective and cost-efficient.
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.