Manufacturers keep stretching two tools over a continuous obligation, and both were built for something else. The pentest is deep but frozen in time. The scanner is continuous but blind to context. ELTON is a third thing: a testing pipeline that carries your device context, runs continuously, and proves what it reports.
There is no manual pentesting in the offering. A decade of physical device pentesting was encoded into a custom harness and pipeline. The experts trained the system. The system runs the tests.
Section 524B and its postmarket cousins describe a standing duty to monitor, identify, and address. Neither legacy tool was shaped for that duty.
Point-in-time by definition. Every engagement starts from zero recon, burns weeks of scarce human bandwidth, and describes the device as it existed that month. The report starts aging on delivery day.
Continuous but context-free. It cannot tell your build from the worst case, so it floods the backlog with theoretical findings and leaves the proving to your engineers.
Continuous and context-loaded. The twin hands it your architecture before testing starts, exploits execute on the real device, and regulatory evidence falls out as a byproduct of the work.
| Dimension | Manual pentest | Scanner | ELTON |
|---|---|---|---|
| Cadence | Annual, or per engagement | Continuous | Continuous |
| Starting context | Zero. Recon rebuilt every time | None. Generic signatures | Digital twin, pre-loaded |
| Findings | Deep but few. Human bandwidth caps the depth | High volume, unproven theory | Exploitability verified on the device |
| Regulatory evidence | A PDF that ages from day one | None | Test case, log, and VEX per finding |
ELTON AI is not a wrapper around a general model. It is a custom harness built by people who spent a decade pentesting physical medical devices, across 2,000+ device tests and work behind 600+ regulatory submissions. That tradecraft was encoded into the pipeline: the protocol tricks, the failure patterns, the places device firmware actually breaks.
So there is no manual pentesting in the offering. Not because hands-on testing stopped mattering, but because the hands-on knowledge now runs as software: every device, every release, without waiting for a calendar slot or a statement of work. Autonomous testing covers how the agents work, and verification covers the gate they have to pass.
A pentest gives you two dots a year. A scanner gives you a steady band of noise. ELTON gives you an unbroken line of verified answers: discovery running against the twin, exploits confirmed on the real device, dispositions updated as each CVE lands.
Delivery fits your lab, not ours. ELTON runs remotely as a managed service, or on your own bench through TestLink™, an out-of-band 5G link to the physical device. Either way the output holds to the same standard: proof over probability, focused on the 1% that matter, scored with an FDA-qualified methodology.
See the pipeline run on one of your devices: continuous discovery, on-device verification, and evidence a reviewer can replay.