ELTON is a medical device cybersecurity company. A decade of hands-on device testing and hundreds of FDA-reviewed submissions, productized as a continuous testing pipeline.
6 of the top 10 medical device manufacturers, and hundreds of emerging ones.
Trusted by 6 of the world's top 10 manufacturers and hundreds of emerging device makers. ELTON has taken more than 600 vulnerability reports through FDA review, and wrote the methodology that many successful submissions rely on.
Exclusively focused on medical devices since 2013. The offering encodes that expertise as test-case-based testing: SAST, DAST, fuzzing, and pentesting.
Backed by an FDA-qualified Medical Device Development Tool (MDDT) for defensible vulnerability reports, pre-validated for use inside an ISO 13485 QMS.
ELTON researchers have disclosed zero-day CVEs across devices and connected products, from infusion-adjacent systems to network hardware. That research informs ELTON AI.
Surgical robots to sequencers, implantables to infusion pumps.
Mobile, web, cloud and network, tested together or one at a time.
An attack that starts in the companion app, pivots through the cloud and lands on the device is one chain, so it is tested as one chain, across every boundary it crosses.
Just the web portal, just the cloud tenant, just the mobile app. Scope follows what you need tested, and the methodology is the same at every layer.
Every finding lands on the same digital twin and in the same report, rated for the product it sits in, whether it came from firmware or from a REST endpoint.
Enterprise vendors test one layer, mostly one surface. A medical device is a regulated system of systems: hardware, embedded, web, mobile, and network, and every decision faces regulatory review.
Submission artifacts map to what FDA actually reviews: CycloneDX SBOMs, the threat model, vulnerability assessments rated with the FDA-qualified MDDT rubric, and testing evidence with narrative, structured for eSTAR's cybersecurity sections and §524B(b). The same format has carried hundreds of 510(k) and PMA submissions.
Every vulnerability keeps its history on the record: identification, triage, rating changes, and the release that fixed it, in a CISA VEX aligned lifecycle with enforced status transitions and required reasons. MTTR and time-to-patch metrics follow FDA postmarket guidance, and any slice exports as an audit-ready report.
Start with one device. We build the twin from documentation your quality system already produces, run AI discovery remotely, and show you the graph: the handful to fix, and the evidence for everything else.
ELTON Cyber is a medical device cybersecurity company. It runs vulnerability testing and management for device manufacturers, premarket and postmarket, on a platform built from more than a decade of hands-on device testing. The objective is to isolate the small share of vulnerabilities that genuinely require fixing and to evidence why the rest do not.
Since 2013, and exclusively on medical devices. That focus is what the platform encodes: test-case-based SAST, DAST, fuzzing and pentesting rather than a generic scan. ELTON has taken more than 600 vulnerability reports through FDA review, and 1,000 or more FDA submissions sit behind the team and the methodology.
Six of the world's top ten medical device manufacturers, plus hundreds of emerging device makers. More than 1,000 medical devices have been tested and approved with ELTON. The company also runs its own vulnerability research, disclosing zero-day CVEs across devices and connected products, and that research feeds the platform.
Because a medical device is a regulated system of systems: hardware, embedded software, web, mobile and network, and every security decision eventually faces regulatory review. Enterprise security vendors test one layer and mostly one surface. ELTON has been exclusively focused on medical devices since 2013 for that reason.
Artifacts mapped to what FDA actually reviews: CycloneDX SBOMs, the threat model, vulnerability assessments rated with the FDA-qualified MDDT rubric, and testing evidence with narrative, structured for the cybersecurity sections of eSTAR and Section 524B(b). The same format has carried hundreds of 510(k) and PMA submissions.