Vulnerabilities, FDA expectations, and real-world findings on AI-enabled medical devices.
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Share of AI/ML deficiencies by content area.
Source: Blue Goat Cyber AI/ML SaMD deficiency subset, 2026. · Unit: % of deficiencies
Share of findings by category (model supply chain, prompt injection, data poisoning, classic web/API).
Source: Blue Goat Cyber AI/ML SaMD penetration test subset, 2026. · Unit: % of findings
Count of CVEs disclosed in 2026 by ML framework.
Source: Public CVE disclosures, 2026, filtered to ML inference frameworks. · Unit: CVEs
Share of AI/ML submissions including a PCCP that addressed cybersecurity-relevant changes.
Source: Blue Goat Cyber AI/ML SaMD submission subset, 2026. · Unit: % of submissions
Share of AI/ML SBOMs that include training-data provenance, model-weight provenance, and inference-runtime version.
Source: Blue Goat Cyber AI/ML SBOM subset, 2026. · Unit: % of SBOMs
Blue Goat Cyber. (2026). AI/ML SaMD Security: Year in Review. https://bluegoatcyber.com/research/ai-ml-samd-security-year-in-review-2026
Canonical report URL: https://bluegoatcyber.com/research/ai-ml-samd-security-year-in-review-2026
