ELTON Cyber
Turning Medical Device Cybersecurity into a Continuous AI-Driven and Defensible Process

Jason Sinchak, Co-Founder & Chief Executive Officer

Medical device manufacturers must support every cybersecurity decision with evidence. Regulators expect them to identify vulnerabilities, assess patient safety risk and justify every decision. That responsibility has become far more demanding as AI uncovers vulnerabilities faster than manual, spreadsheet-driven processes can manage.

“The manual process right now is just not possible to execute due to AI finding vulnerabilities at a much higher pace and volume than in the past,” says Jason Sinchak, Co-Founder and Chief Executive Officer of ELTON.

Built specifically for medical device manufacturers, ELTON automates vulnerability testing, exploitability analysis and continuous compliance while ensuring every vulnerability result is evidence-based and aligned with regulatory expectations. Rather than simply finding more vulnerabilities, as evidenced by ELTON’s AI pentesting pipeline, the platform enables manufacturers to determine which ones actually matter, prove why the rest do not, and defend those decisions during regulatory reviews and audits.

AI-Native Pentesting for Medical Devices

ELTON runs penetration testing through a custom AI harness rather than a consulting engagement. The harness encodes 13 years of hands-on medical device pentesting, spanning 10,000+ device tests and the work behind 1,000+ FDA submissions, as executable test cases.

A full pentest executes in hours rather than weeks. Because the pipeline is not bound by billable hours, it goes deeper than a time-boxed engagement and produces better results than a pentester with 10 years of experience. Testing runs continuously, on every release, under one subscription with no consulting fees, no overages and no vendor calendar.

Looking Beyond Vulnerability Scores

Most cybersecurity tools identify vulnerabilities but provide little insight into how those vulnerabilities affect a specific medical device. In medical devices, context matters. A vulnerability rated critical in one product may present little risk in another because of its architecture and security controls.

ELTON addresses that gap by creating a digital twin before vulnerabilities are evaluated. The platform combines existing quality system documentation, software analysis and real on-product telemetry to build a cybersecurity blueprint of how the product operates and various attack surfaces, the ground truth every finding is measured against.

Medical devices only have a limited amount of attack surface, and in theory a limited amount of directly exploitable vulnerabilities, but proving that to regulatory is more difficult than it appears. Attack surfaces, including network connections, wireless interfaces, USB ports and user interactions are mapped alongside existing security controls. Each vulnerability is analyzed in context rather than relying solely on public severity ratings. If it is not exploitable on that device, ELTON does not treat it as a vulnerability. The resulting assessment follows an FDA-compliant methodology, enabling manufacturers to produce consistent, defensible, evidence-based risk evaluations across product portfolios.

Making Compliance Continuous

Cybersecurity is an ongoing regulatory responsibility. Manufacturers must continuously identify, assess, document and monitor vulnerabilities throughout a device’s lifecycle.

ELTON integrates vulnerability discovery, penetration testing, software bill of materials (SBOM) analysis, static and dynamic code analysis, fuzzing and continuous monitoring into a single workflow. Every assessment, mitigation decision and supporting evidence is captured in a complete audit trail. Large manufacturers gain portfolio-wide consistency, while smaller companies access enterprise-grade cybersecurity through ELTON’s fixed-price subscription, delivered as a managed program.

Applying AI with Accountability

AI has collapsed the cost of vulnerability discovery to nearly zero, making manual analysis unsustainable.

ELTON uses AI to accelerate digital twin creation, identify vulnerabilities and build the tools that test the device. Customer source code, firmware and findings stay inside the pipeline and are never sent to a model, and AI is not used to make vulnerability management decisions. Risk determinations remain grounded in evidence-based analysis, while every finding becomes part of a continuously updated source of truth.

Exploitability is verified against the real device rather than theorized, and the company’s roadmap extends that automated exploit validation to laboratory systems, so manufacturers can confirm whether vulnerabilities are genuinely exploitable and focus attention on issues requiring action.

Delivering Answers When They Matter Most

One customer engagement demonstrates the value of contextual analysis and defensible evidence.

A manufacturer preparing for regulatory review had accumulated numerous vulnerabilities initially rated high or critical because they had never been fully analyzed. Left unresolved, those ratings risked FDA warning letters, delayed approvals or recalls.

ELTON built a digital twin, verified each reported vulnerability for exploitability using AI and reassessed each issue according to the device’s architecture, attack surfaces and existing security controls. Many were defensibly downgraded because public severity ratings failed to reflect how the product actually operated.

Documentation that normally required weeks was produced in about one day. Instead of presenting regulators with an unexplained list of severe vulnerabilities, the manufacturer demonstrated why each rating had changed and supported every decision with regulatory evidence.

As connected medical devices continue to evolve and AI accelerates vulnerability discovery, manufacturers need more than tools that identify security issues. They need a scalable process that continuously analyzes vulnerabilities, supports every decision with evidence and withstands regulatory scrutiny. ELTON is helping manufacturers make that transition through a continuous, contextual and defensible approach to cybersecurity, one that finds the 1% of vulnerabilities that require fixing and proves why the other 99% do not.