ESLFDA AI Device Intelligence

Medscape Medical NewsFDA Device Recall Problems Raise Questions About Patient Safety, Clinician Liability - Medscape Medical News examines how persistent problems in the FDA device recall system raise questions about patient safety and clinician li… Read more →All articles

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De NovoRadiology

Cloud-Based AI Diagnostic SaaS

?Before ESL

• Containerized deployment with 47 dependencies - no inventory
• No §524B cybersecurity evidence prepared
• Static analysis backlog of 180 findings (CERT C/C++, CWE)
• Unit tests covered only 34% of statements - no branch coverage

VAfter ESL

• Container SBOM generated by SBOMator™ (CycloneDX + VEX)
• Section 524B evidence mapping: premarket + postmarket monitoring plan
• ESL fixed 41 real defects; remaining 139 triaged as false positives or accepted deviations
• 92% branch coverage with documented justification for uncovered error-handling paths
• CI pipeline integrated with controlled baselines and release gates

Result: De Novo granted. FDA reviewer specifically noted the cybersecurity evidence package as comprehensive and well-organized.

Bring ESL the software - not a cleaned-up demo

We will build, clean and connect the evidence. Start with a software evidence scoping workshop.

Schedule Scoping Workshop →