MedCrypt vs Sternum (2026)
Both sell to device manufacturers, for different parts of the job. MedCrypt takes a device team through the FDA premarket cybersecurity submission, with threat modeling, document generation, audit scans and advisory hours from former FDA reviewers. Helm manages SBOMs and vulnerabilities across a portfolio. Guardian covers encryption, key management and identity for fielded devices. Sternum protects the device after it ships. Its EIV technology instruments firmware so that an attempt to divert the code is blocked on the device itself, with overhead the company puts at 1 to 3 percent. A cloud platform fed by an SDK on the device adds logs, forensics and an anomaly engine that trains on each device's routines. Choose MedCrypt for the submission and its paperwork, at published prices; choose Sternum to block exploitation on devices in the field.
- You are preparing an FDA premarket cybersecurity submission.
- The submission package should be audited against FDA requirements before filing.
- Published prices suit how you buy: $35,000 per product line a year, or $499 per user a month for Helm.
- Devices in the field need runtime protection that works offline.
- Legacy devices on FreeRTOS, Zephyr or embedded Linux need protection too.
- Device telemetry should feed your SIEM or SOC.
This comparison is published by AI Health Index, an independent research platform that compares healthcare AI vendors objectively. MedCrypt and Sternum are each graded against the same capability taxonomy, from each vendor's own public materials and the regulatory record, under the AI Health Index verification standard. No vendor pays for placement, and no vendor has reviewed this page. How this evidence is graded
Plain facts
| Fact | MedCrypt | Sternum |
|---|---|---|
| Primary category | Healthcare Cybersecurity | Healthcare Cybersecurity |
| Founded | 2016 | 2018 |
| Headquarters | Solana Beach, California, United States | Tel Aviv, Israel |
| Website | medcrypt.com | sternumiot.com |
Side by Side
Select any grade to read the note behind it.
Each vendor in one paragraph
Written to be quoted whole. Each paragraph opens the AI Health Index profile of the vendor: what the product is, who buys it and what it does.
Medcrypt sells cybersecurity compliance software and services to medical device manufacturers rather than to hospitals. Its lead offer, Medcrypt Security Intelligence (MSI), takes a device team through an FDA premarket cybersecurity submission and what follows it: a free readiness check scored against the domains FDA reviews, threat modeling and risk assessment, document generation, audit scans of a submission package against FDA requirements, deficiency letter responses, and postmarket monitoring through MedISAO membership, with advisory hours from former FDA reviewers in every tier.
Source: AI Health Index, September 2026
Sternum sells embedded security that device manufacturers build into their own products, medical devices among them. Its core technology, EIV embedded integrity verification, is patented binary instrumentation: it profiles a device's firmware, including third party libraries, and places checks on execution flow and memory so that an attempt to divert the code is blocked on the device itself, whether or not the device is connected, with overhead the company puts at 1 to 3 percent.
Source: AI Health Index, September 2026
Questions buyers ask
How do MedCrypt and Sternum work with the EHR?
For MedCrypt, the Helm documentation covers an API and SDK, a GitHub Action and an Azure DevOps extension that ingest SBOMs from build pipelines, and exports that send vulnerabilities to Jira and to AWS; SBOMs are accepted in CycloneDX and SPDX, and reports export as FDA SBOM, VEX and VDR files. Threat modeling works from AWS, Visio and draw.io architecture diagrams.
EIV integrates into the build, testing and deployment process and supports named embedded platforms (FreeRTOS, Zephyr, QNX, Micrium, Mbed OS, Azure ThreadX and embedded Linux), and the Linux Foundation describes Sternum as a Zephyr partner. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 30, 2026. No vendor pays for placement.
How are MedCrypt and Sternum priced and sold?
In MedCrypt's case, the pricing page lists a free readiness check ("No login wall, no sales call"), Medcrypt Security Intelligence at $35,000 per product line per year with 15 expert advisory hours and unlimited users, and a custom Enterprise tier with volume pricing across product lines; penetration testing is a scoped add-on.
Sternum offers a free evaluation kit: an ARM-based development board, a trial of EIV runtime protection and a trial account on the threat detection and observability platform, requested by form; an OpenWrt evaluation is marked coming soon. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 30, 2026. No vendor pays for placement.
How do MedCrypt and Sternum handle patient data?
With MedCrypt, the product handles device manufacturers' software bills of materials, threat models, risk assessments and submission packages, which map a device's known weaknesses; it is not described as handling patient data, and Guardian's device telemetry is not described either. The only privacy document is a website policy dated 18 September 2023, written for visitors to the Medcrypt site.
Sternum's privacy policy covers personal data of device end users that customers submit through the service, with Sternum acting as the customer's processor and keeping that data according to the customer's instructions; it says Sternum does not review submitted data and cannot classify it as personal or sensitive. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 30, 2026. No vendor pays for placement.
Which settings and specialties do MedCrypt and Sternum cover?
For MedCrypt, the platform serves medical device manufacturers: regulatory affairs, quality, product security and engineering teams preparing FDA 510(k), De Novo and PMA submissions, EU MDR and Health Canada filings, and postmarket monitoring for the life of a device. Case studies name device types rather than customers: a cardiac device PMA, surgical robotics, a radiotherapy system, a 3D mapping system and a 100-plus device portfolio.
Sternum sells to manufacturers of connected devices across medical, industrial, critical infrastructure and consumer IoT, new and legacy, on RTOS and embedded Linux, and presents EIV as IDS/IPS for medical devices. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 30, 2026. No vendor pays for placement.
Related comparisons
Other published head to head assessments involving these vendors or their closest peers. The full set for this category is on the Healthcare Cybersecurity page.
Both records were reviewed on this site in September 2026. Neither claims an FDA clearance. Neither states its own regulatory position. Neither publishes a security attestation, subprocessor list or business associate position. MedCrypt's home page says "100% FDA approval rate, guaranteed" and states no terms for the guarantee. Sternum says EIV prevents all code and memory manipulation attempts. The same site reports 96.5 percent prevention in an unnamed benchmark. Sternum's device telemetry goes to its own cloud platform, with no hosting location published. MedCrypt publishes no retention period or position on training with customer data. Sternum publishes no price and offers a free evaluation kit.
Ask MedCrypt what its guarantee commits it to if a submission is refused, and ask Sternum for the benchmark behind its 96.5 percent.