MedCrypt vs Sternum (2026)
Both serve the device manufacturer, but they solve different halves of the obligation. MedCrypt is built for the submission: it maps precisely to the enforceable requirements under Section 524B, names its exploitability sources openly, and produces the SBOM, VEX, and VDR reports a reviewer expects, with regulatory literacy as the genuine product. Sternum is built for the field: its patented Embedded Integrity Verification blocks execution flow diversion at runtime, defending the device against unknown exploits even when disconnected, which addresses the postmarket patching problem documentation cannot. Neither leans on machine learning, and this index grades both C on AI centrality and says why rather than inflating it, MedCrypt a rules engine over public feeds, Sternum deterministic by design. If your failure mode is getting through the FDA submission with defensible documentation, start with MedCrypt. If your failure mode is protecting deployed clinical devices you cannot reliably patch, start with Sternum.
- The clearest regulatory literacy in the lane, graded A on FDA status: the product maps directly to the enforceable obligations under Section 524B, from SBOM minimum elements through per vulnerability risk assessments to postmarket monitoring, backed by published analysis of real FDA premarket deficiency patterns.
- Auditable inputs, graded A on model transparency: exploitability is built explicitly on EPSS, CISA KEV, ExploitDB, Metasploit, NVD, and CWE Top 25, named public sources a buyer can evaluate, and it produces FDA ready SBOM, VEX, and VDR reports.
- The submission is the job: Helm manages SBOM generation, validation, and vulnerability tracking across a device portfolio and determines which vulnerabilities are actually relevant to a given device rather than listing every matching CVE.
- Defend the device in the field, regardless of which flaw: patented Embedded Integrity Verification blocks any attempt to divert the execution flow, stopping unknown and zero day exploits without knowing the vulnerability, graded A on autonomy.
- The strongest deployment position in the category, graded A: protection runs inside the firmware and works when the device is disconnected, at a reported 1 to 3 percent overhead, reaching isolated and legacy equipment that documentation tooling never touches.
- A rare commercial signal, graded B on transparency where MedCrypt is C: a genuine free licence covering up to three OpenWrt devices gives engineers a hands on evaluation path without a sales conversation, unique in this category.
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 | Not recorded | 2018 |
| Headquarters | San Diego, California, United States | Tel Aviv, Israel |
| Website | medcrypt.com | sternumiot.com |
Side by Side
Each record in one paragraph
Written to be quoted whole. Each paragraph states what the AI Health Index verified about the vendor, with the caveats attached. Generated from this pair’s live capability grades, so it moves when a grade moves.
The AI Health Index awards MedCrypt its top capability grade on several axes, including Model and Technology Transparency, Model Supply Chain Disclosure and AI Safety and PHI Stewardship. Set against Sternum, MedCrypt grades higher on FDA and Regulatory Status. Grades reflect evidence the AI Health Index could verify at the last review, so a low grade records disclosure the vendor has not published rather than a capability it has been shown to lack.
Source: AI Health Index, July 2026
The AI Health Index awards Sternum its top capability grade on several axes, including Autonomy and Oversight Model, Model and Technology Transparency and Model Supply Chain Disclosure. Set against MedCrypt, Sternum grades higher on several axes, including Autonomy and Oversight Model, AI Governance and Bias Disclosure and AI Liability and Recourse. Grades reflect evidence the AI Health Index could verify at the last review, so a low grade records disclosure the vendor has not published rather than a capability it has been shown to lack.
Source: AI Health Index, July 2026
Questions buyers ask
Should we choose MedCrypt or Sternum?
On the axes where the AI Health Index separates them, MedCrypt grades higher on FDA and Regulatory Status, and Sternum grades higher on several axes, including Autonomy and Oversight Model, AI Governance and Bias Disclosure and AI Liability and Recourse. Sternum leads on the greater share of scored axes, but the split means the decision turns on which constraint is binding rather than on an overall winner.
Where do MedCrypt and Sternum differ most?
The widest separation the AI Health Index records between MedCrypt and Sternum is on Deployment Model and Data Residency, where MedCrypt grades C and Sternum grades A. That axis sits in the Integration and Deployment group, so it should carry the most weight for a buyer whose binding constraint is how the product lands in the stack already in place.
Where do MedCrypt and Sternum grade the same?
The AI Health Index grades MedCrypt and Sternum the same on several axes, including AI Centrality, Model and Technology Transparency and Model Supply Chain Disclosure. Neither holds an advantage the index can evidence on those axes, so they should not carry weight in a selection between these two.
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 Administrative Automation page.
These two sit at opposite ends of the manufacturer obligation: MedCrypt produces the premarket submission documentation, Sternum provides the postmarket runtime defence, and Sternum frames its regulatory value practically, that runtime prevention reduces dependence on field patching, graded B on FDA status against MedCrypt's A statutory specificity. Both grade A on PHI and neither processes patient data.
Both grade C on AI centrality, and the reason is the same honest one in each case: MedCrypt's core is a rules engine over public feeds, and Sternum's flagship Embedded Integrity Verification is deterministic rather than model driven, which is precisely what lets Sternum earn A on autonomy since a deterministic check carries no false positive exposure. Both grade C on evidence with no independent benchmark located. Neither publishes a security attestation. MedCrypt publishes no pricing; Sternum publishes a free tier but no premium rate.